Pathologically confirmed metastatic breast cancer
No prior systemic treatment for metastatic breast cancer
Metastatic breast cancer (measurable or evaluable including bone metastases only)
Any number of prior therapies for metastatic breast cancer is allowed; patients with weakly estrogen receptor positive breast cancer who received any number of endocrine agents for metastatic breast cancer will also be eligible
Metastatic non-gynecologic or breast primaries
No prior chemotherapy or trastuzumab for treatment of metastatic breast cancer
Stage 4 (metastatic) breast cancer
Metastatic non-small cell lung cancer (NSCLC), metastatic urothelial carcinoma or microsatellite instability high metastatic colorectal cancer (except for patients enrolling based on elevated TMB); For patients enrolling based on elevated TMB, patients with metastatic NSCLC, metastatic urothelial carcinoma or metastatic colorectal cancer will be allowed to enroll
Prior therapies for metastatic breast cancer\r\n* Frontline patients who have not received prior systemic therapy for metastatic breast cancer are eligible, \r\n* Patients who have received =< 2 prior chemotherapy regimens for metastatic breast cancer are eligible
Metastatic melanoma, gastrointestinal, or genitourinary cancer with at least one lesion that is resectable; only patients with metastatic gastrointestinal cancer will be eligible for enrollment on the phase I portion of the study; patients with metastatic melanoma, gastrointestinal, or genitourinary cancer will be eligible for enrollment on the phase II portion of the study
Women with metastatic breast cancer who are eligible for capecitabine monotherapy; for HER2 positive breast cancer, concurrent trastuzumab is allowed OR
Patients (both male and female) with advanced/metastatic GI cancers eligible for capecitabine monotherapy, including metastatic colorectal cancer, metastatic gastric and esophageal cancers, and unresectable or metastatic pancreatic cancer and cholangiocarcinoma, including gall bladder carcinoma, concurrent trastuzumab is allowed for HER2 positive gastric/esophageal cancer
Patients with metastatic breast cancer
At least one prior line of therapy for metastatic breast cancer
Patients who had received therapy for metastatic breast cancer (other than that described above)
Patients with new or progressive breast cancer metastatic to brain will be eligible provided:
Metastatic (stage IV) triple negative breast cancer that has progressed after at least one prior chemotherapy regimen in the metastatic setting; non-measurable disease (i.e. bone metastases) is permitted
Stage I-III non-metastatic breast cancer\r\n* Inflammatory breast cancer (T4d) is acceptable\r\n* Patients with oligo-metastatic disease who are being treated with a curative intent as per the treating physician are eligible as well
gBRCAm HER2-negative metastatic breast cancer (module 2)
Patients with histologically confirmed metastatic melanoma, metastatic non-small cell lung cancer, metastatic breast cancer, or metastatic pancreatic adenocarcinoma relapsed or refractory to therapy as outlined below or patients with these malignancies who have declined, are or have become unable to tolerate (e.g. progressive chemotherapy-associated peripheral neuropathy), or were not eligible for standard therapy\r\n* Metastatic melanoma patients at any line of therapy\r\n* Metastatic non-small cell lung cancer patients who have relapsed or are refractory to at least one line of systemic anti-cancer therapy for metastatic disease, including cytotoxic chemotherapy or targeted therapy\r\n* Metastatic breast cancer patients who have relapsed or are refractory to at least one line of systemic anti-cancer therapy for metastatic disease, such as cytotoxic chemotherapy, hormonal therapy, or targeted therapy\r\n* Metastatic pancreatic adenocarcinoma who have relapsed or are refractory to at least one line of systemic anti-cancer therapy for metastatic disease, such as cytotoxic chemotherapy or targeted therapy
Metastatic breast cancer
Evidence of metastatic/stage 4 breast cancer
Must have progressed on at least 1 prior systemic therapy regimen for the treatment of advanced breast or other non-breast metastatic cancer; there is no upper limit on the number of prior therapies
Patients must have either A) histologic documentation of metastatic or locally advanced breast cancer by core needle or incisional biopsy, or B) history of breast cancer with radiologic evidence of bone-only metastatic disease
There must be documentation that the patient has evidence of measurable metastatic breast cancer. Histologic confirmation of metastatic disease is not required.
Metastatic or locoregionally recurrent HER2-negative breast cancer; resectable disease allowed
Patient has metastatic breast cancer that is not suitable for surgery or radiation therapy for local disease control at the time of screening.
Patients planned for pre-operative chemotherapy or those with known metastatic breast cancer
Subject has received more than 1 prior line of chemotherapy treatment for metastatic breast cancer
All patients must have recurrent or metastatic HER2-positive breast cancer; diagnosed by biopsy
Patients who have received prior lapatinib for metastatic breast cancer will be excluded
Prior treatment with at least two (2) HER2-directed regimens for metastatic breast cancer.
Received prior trastuzumab or chemotherapy for metastatic breast cancer except if patient has CNS as only site of metastatic disease
Received either one or two prior systemic treatments for metastatic breast cancer and have documented disease progression on or after the most recent therapy
Metastatic Breast Cancer: Human Epidermal Growth Factor Receptor 2 - negative (HER2(-)) recurrent Metastatic Breast Cancer:
Proven diagnosis of metastatic breast cancer (MBC).
Patients with chemotherapy for metastatic disease (patients with 0-3 prior lines of chemotherapy for metastatic breast cancer [MBC])
Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen for metastatic breast cancer
Metastatic breast cancer patients currently on hormonal therapy as first- or second-line are not permitted
Are currently receiving or have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer
Subjects with more than 2 events of disease progression after the development of metastatic breast cancer.
Patients with metastatic breast cancer
Patients with documented HER2-positive metastatic disease are not eligible, even if their primary breast cancer was HER2-negative
Biopsy proven breast carcinoma which is persistent and metastatic or recurrent and metastatic.
Participants must have histologically confirmed invasive breast cancer that is metastatic or unresectable locally advanced; histological documentation of metastatic/recurrent breast cancer is not required if there is unequivocal evidence for recurrence of the breast cancer
Evidence of metastatic breast cancer
Progression on at least 2 lines of anti-HER2-targeted therapies for metastatic breast cancer (MBC)
Patients with metastatic cancer
Men with metastatic or unresectable breast cancer are eligible
More than 2 prior lines of chemotherapy for metastatic breast cancer.
HER2+ metastatic breast cancer, documented as HER2+ by FISH and/or 3+ staining by immunohistochemistry.
Patients must have had exposure to at least 1 and no more than 3 prior chemotherapy regimens for the treatment of metastatic breast cancer
Patients must not have evidence of metastatic tumor or other cancer
No prior treatment for metastatic breast cancer
Patients who have received prior hormonal or any other systemic therapy for metastatic breast cancer.
Participants must have histologically confirmed invasive breast cancer that is metastatic or unresectable locally advanced; histological documentation of metastatic/recurrent breast cancer is not required if there is unequivocal evidence for recurrence of the breast cancer
Patients with breast cancer must have had at least one prior chemotherapy regimen for metastatic disease; additionally, patients with breast cancer must have received prior tamoxifen and/or aromatase inhibitor therapy (if post-menopausal) with at least one hormonal regimen in the metastatic setting; patients with HER2+ breast cancer must have progressed after at least one prior HER2-directed regimen (trastuzumab, lapatinib) for metastatic disease\r\n* All other patients must have disease that has progressed following at least one line of standard therapy; prior therapy with tamoxifen is allowed
Evidence of metastatic breast cancer following a standard tumor staging work-up
Patients must have histologically proven breast cancer with metastatic disease to the brain
Patients with metastatic breast cancer
Metastatic cervical or uterine cancer.
Histologically verified breast cancer with distant metastases (metastatic breast cancer)
Hormone-refractory metastatic breast cancer defined as disease progression within 6 months from starting most recent hormonal therapy
Patients with current local, loco-regional relapse and/or distant metastatic breast cancer
Metastatic cancer
Diagnosed with metastatic breast cancer, caregiver to patient with metastatic breast cancer (MBC) who is enrolled in this study, or MBC provider
Have metastatic cancer
Patients with metastatic breast cancer
Metastatic breast cancer
Patients with metastatic breast cancer are not eligible to participate
Histologically confirmed breast cancer and no evidence of metastatic disease with a recommendation to begin chemotherapy within 4 weeks
Patients with metastatic cancer or a second primary cancer
Active cancer/metastatic cancer
Patients with metastatic breast cancer
Metastatic breast or other cancer
Metastatic breast or other cancer
Have been diagnosed with non-metastatic breast cancer (stages 0-III)
Prior history or evidence of metastatic breast cancer
Prior history or evidence of metastatic breast cancer
More than one metastatic cancer active in the last 5 years
Patients must already be known to have metastatic, incurable cancer
Inclusion Criteria:\n\n        Cisplatin Combination Expansion:\n\n        Arm 1:Patients with TNBC with no prior cytotoxic chemotherapy therapy in the metastatic\n        setting; Arm 2: Patients with TNBC and one or two prior cytotoxic therapies in the\n        metastatic setting.\n\n          -  Arm A: castrate resistant prostate cancer, advanced breast cancer, or non-small cell\n             lunch cancer that are candidates for treatment with a docetaxel-based combination.\n\n          -  Arm B: Urothelial transitional cell cancer, triple negative breast cancer, ovarian\n             cancer or non small cell lunch cancer that are candidates for a cisplatin-based\n             combination.\n\n          -  Arm C: Her2+ breast cancer refractory to prior herceptin or lapatinib, her2+\n             esophagal-gastric cancer, head and neck squamous cell cancer, or non small cell lunch\n             cancer that are candidates for treatment with a dacomitinib-based combination.\n\n          -  Availability of archival tumor biopsy sample or willing to provide fresh biopsy if not\n             available.\n\n          -  Eastern Cooperative Oncology Group [ECOG] performance must be 0 or 1.\n\n          -  Adequate bone marrow, renal and liver function.\n\n        Exclusion Criteria:\n\n          -  Prior therapy for Cisplatin Combination Expansion:\n\n               -  Prior platinum (carboplatin or cisplatin) in either the adjuvant or metastatic\n                  setting;\n\n               -  Prior radiation to >25% bone marrow as estimated by the Investigator.\n\n          -  Patients with known symptomatic brain metastases.\n\n          -  Chemotherapy, radiotherapy, biologics or investigational agent within 4 weeks of the\n             lead-in dose.\n\n          -  Major surgery within 4 weeks of the baseline disease assessments.\n\n          -  >2 prior regimens containing cytotoxic chemotherapy in the metastatic setting.\n\n          -  Active bacterial, fungal or viral infection.\n\n          -  Uncontrolled or significant cardiovascular disease.
Diagnosed with non-metastatic (i.e., stages I – III) cancer
No prior treatment with chemotherapy for a diagnosis of locoregionally recurrent or metastatic breast cancer is allowed.
Patients have either metastatic or non-metastatic lung cancer as defined in history and physical
Histopathologically confirmed metastatic breast cancer
T4 tumors including inflammatory breast cancer
T4 tumors including inflammatory breast cancer
T4 tumors including inflammatory breast cancer
T4 tumors, known metastatic disease, recurrent disease, inflammatory breast cancer, multicentric disease, and/or synchronous bilateral breast cancer
Women with inflammatory breast cancer as evidenced by clinical assessment
T4 tumors including inflammatory breast cancer
PHASE I: Women diagnosed with Paget’s disease, inflammatory breast cancer or a phyllodes tumor
Women with T4 disease, including inflammatory breast cancer
Patients must have completed all chemotherapy prior to surgery; sandwich chemotherapy is not allowed (i.e. chemotherapy planned to be given after surgery); patients must have completed at least 4 cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen without evidence of disease progression in the breast or the lymph nodes\r\n* Note: Delays/dose modifications due to toxicities/adverse events are allowed as long as a minimum of 4 cycles of neoadjuvant chemotherapy is administered; more than 4 cycles of neoadjuvant chemotherapy (NAC) may be administered at the discretion of the treating medical oncologist
All patients must have a clinically negative axilla (no bulky adenopathy) on physical examination documented at the completion of neoadjuvant chemotherapy\r\n* Note: an ultrasound of the axilla is not required at completion of neoadjuvant chemotherapy; if performed, its findings do NOT impact eligibility
No more than 8 weeks of neoadjuvant endocrine therapy prior to the start of neoadjuvant chemotherapy
No neoadjuvant radiation therapy
No SLN surgery/excisional biopsy for pathological confirmation of axillary status prior to or during neoadjuvant chemotherapy
Patients must have completed neoadjuvant taxane +/- anthracycline; patients must NOT have received cisplatin or carboplatin or capecitabine as part of their neoadjuvant therapy regimen\r\n* NOTE: Patients who received preoperative therapy as part of a clinical trial may enroll\r\n* NOTE: Patients that were not able to complete their planned neoadjuvant chemotherapy for any reason (i.e. toxicities, etc.) are eligible to participate as long as no further systemic standard of care therapy is planned by the treating physician
No neoadjuvant chemotherapy =< 4 weeks before pre-registration
Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated
Patients must have had neoadjuvant chemotherapy followed by surgery; the recommended neoadjuvant treatment should include 16-24 weeks of a third generation chemotherapy regimen as recommended by National Comprehensive Cancer Network (NCCN) guidelines for triple negative breast cancer (examples include dose dense adriamycin-cytoxan [AC] followed by dose-dense paclitaxel; weekly paclitaxel x 12 followed or preceded by cyclophosphamide-adriamycin-fluorouracil [FAC], fluorouracil-epirubicin-cytoxan [FEC], AC or dose dense AC; docetaxel either followed or preceded by FEC/FAC or AC; carboplatin-containing neoadjuvant chemotherapy is also allowed); patients who cannot complete all planned treatment cycles for any reason are considered high risk and therefore are eligible for the study if they have residual disease; patients must have resolution of adverse event(s) of the most recent prior chemotherapy to grade 1 or less, except alopecia and =< grade 2 neuropathy which are allowed
STEP 1: NEOADJUVANT
Patient must have received at least two cycles of triplet neoadjuvant therapy (all three drugs) during step 1
Patient must be registered to step 2 no less than 21 days and no more than 90 days after the end of their final cycle of neoadjuvant therapy
One of the breast disease stages listed below:\r\n* Note: In the definitions below, definitive surgery is defined as the final surgery performed to obtain clear surgical margins\r\n* Neoadjuvant chemotherapy was not administered\r\n** If neoadjuvant chemotherapy was NOT administered, pathologic staging must be T1-3, N1-2a following definitive surgery\r\n* Neoadjuvant chemotherapy was administered\r\n** If prior to initiation of neoadjuvant chemotherapy clinical staging was T1-3, N0, pathologic staging must be T1-3, N1-2a following definitive surgery\r\n** If prior to initiation of neoadjuvant chemotherapy clinical staging was T1-3, N1, pathologic staging must be T0-3, N0-2a following definitive surgery\r\n** If prior to initiation of neoadjuvant chemotherapy there was cytologic or pathologic confirmation of axillary nodal involvement (per any of the criteria listed below), pathologic staging must be T0-3, N0-2a following definitive surgery\r\n*** Positive fine-needle aspiration (FNA) (ie, demonstrating malignant cells)\r\n*** Positive core needle biopsy (ie, demonstrating invasive adenocarcinoma)\r\n*** Positive sentinel lymph node biopsy (ie, demonstrating invasive adenocarcinoma)
Prior neoadjuvant chemo or biologic therapy for current breast cancer within 4 weeks prior to planned surgery [Period 1]
Candidate for neoadjuvant chemotherapy
Patient Received neoadjuvant chemoradiation (4-10 weeks prior to surgery)
Subjects with MIBC not meeting the above criteria are still eligible provided the patient declines neoadjuvant cisplatin-based chemotherapy, after specific informed consent describing the known benefits of cisplatin-based chemotherapy
Plans for administration of neoadjuvant chemotherapy or hormonal therapy
Eligible for neoadjuvant chemotherapy
Subjects undergoing neoadjuvant chemotherapy or neoadjuvant endocrine therapy
Must not have received nor be planned for neoadjuvant chemotherapy prior to SABR or surgery
Subjects must not have received or plan to receive neoadjuvant chemotherapy either before radiotherapy or before surgery
Chemotherapy is planned for the patient in the neoadjuvant setting
Received neoadjuvant chemotherapy
Plan for neoadjuvant chemoradiation
A female patient who is a woman of child-bearing potential (WCBP) and a male patient with a partner who is a WCBP must agree to use a medically accepted method for preventing pregnancy for the duration of immunotherapy and neoadjuvant chemotherapy and until after completion of breast surgery or, for patients who do not receive neoadjuvant chemotherapy, for a minimum of 4 months following the last dose of pembrolizumab
Prior treatment with neoadjuvant therapy
NEOADJUVANT COHORT
Consideration for neoadjuvant therapy
Planned neoadjuvant chemotherapy for breast cancer as determined by the judgment of the medical oncologist
A disposition to neoadjuvant chemotherapy with planned interval tumor reductive surgery after 3 complete cycles of treatment
No prior therapy for current breast cancer and not planning neoadjuvant chemotherapy
Contraindication to repeat breast biopsy (neoadjuvant chemotherapy group)
Patients who have received any non-anti-folate containing neoadjuvant or systemic chemotherapy are eligible; any prior intravesical therapy, or immunotherapy is allowed
Patients must have an intact evaluable primary tumor or biopsy proven axillary node involvement with at least 1.0 centimeter (cm) smallest dimension based on imaging after neoadjuvant anthracycline-based chemotherapy and prior to initiation of neoadjuvant chemotherapy under this protocol; baseline measurements and evaluations must be obtained within 4 weeks of registration to the study; all areas of disease should be recorded in order to assess response and uniformity of response to therapy
Inoperable breast cancer even after neoadjuvant treatment as assessed by the treating surgical oncologist
Participants with preoperatively staged T3, N1, or N2 tumors who return > 12 weeks following completion of neoadjuvant chemoradiation therapy (CRT)
Neoadjuvant chemotherapy
Patients who were exposed to neoadjuvant chemotherapy or chemotherapy after prostatectomy
Received chemotherapy, radiotherapy, or biologic therapy within the last 30 days (neoadjuvant chemotherapy excluded)
Received chemotherapy, radiotherapy, or biologic therapy within the last 30 days (neoadjuvant chemotherapy excluded)
Prior or planned neoadjuvant systemic therapy for breast cancer
Neoadjuvant chemotherapy will be permitted prior to the initiation of SBRT radiation therapy on this clinical trial; there must be a minimum of 2 weeks between the completion of any neoadjuvant chemotherapy and the beginning of SBRT radiation therapy; furthermore, restaging must be done prior to registration to ensure that patients remain resectable
Patients who will receive neoadjuvant chemotherapy are not eligible
Patients treated with neoadjuvant chemotherapy are not eligible
Neoadjuvant chemotherapy for current malignancy
Patient must have a medical oncology consult and be recommended to receive or are currently receiving neoadjuvant chemotherapy for a stage IIB through IV carcinoma
EXCLUSION CRITERIA FOR REGISTRATION: subjects receiving neoadjuvant chemotherapy for whom interval debulking surgery (assuming adequate response to therapy) is not planned
Planned neoadjuvant chemoRT treatment must conform to NCCN guidelines.
Other than the 3 cycles of neoadjuvant chemotherapy and surgery (mentioned above), must not have received other treatment for their gastric cancer.
Patient has at least one of the following:\r\n* Pathologic N1-3\r\n* Pathologic T3\r\n* Neoadjuvant chemotherapy and did not achieve pathologic response at time of surgery
Have had an R0/R1 resection of PDA following neoadjuvant chemotherapy
Any cytotoxic treatments, such as neoadjuvant chemotherapy, planned before subsequent surgical procedure
Patients must have received neoadjuvant chemotherapy of at least 16 weeks. This period must include 6 weeks of a taxane -containing neoadjuvant therapy (Exception: For patients with progressive disease that occurred after at least 6 weeks of taxane-containing neoadjuvant treatment, a total treatment period of less than 16 weeks is also eligible).
Neoadjuvant chemotherapy before or after prostatectomy
Not be receiving neoadjuvant hormonal or chemotherapy (other clinical trials)
NEOADJUVANT COHORT
Prior neoadjuvant FOLFIRINOX
Undergone neoadjuvant chemotherapy
Neoadjuvant chemotherapy
Any neoadjuvant chemotherapy
Patients who have received neoadjuvant chemotherapy or neoadjuvant hormonal therapy for the current cancer
Neoadjuvant radiation therapy or chemotherapy for cervical cancer
Complete pathologic response to neoadjuvant chemotherapy (NAC).
Patients must not have received neoadjuvant chemotherapy for the present disease
Completed all planned therapy for T >= 1.0 cm, Nx, M0 or Tx, N >= N1, M0  triple negative breast cancer (TNBC) (American Joint Committee on Cancer, 7th edition) meeting the following guidelines:\r\n* Received neoadjuvant chemotherapy and/or completed adjuvant chemotherapy with or without radiation; (the patient may have had adjuvant and/or neoadjuvant chemotherapy for their disease); patients who received neoadjuvant chemotherapy may have either residual disease or a complete response; adjuvant/neoadjuvant chemotherapy regimens must include at least 4 cycles of a standard chemotherapy regimen, and generally this should include one of the generally accepted standard regimens (including but not limited to: doxorubicin hydrochloride, cyclophosphamide and paclitaxel [AC-T], Taxotere and cyclophosphamide [TC], doxorubicin hydrochloride and cyclophosphamide [AC], or cyclophosphamide, methotrexate and fluorouracil [CMF]); for patients who received their standard chemotherapy as part of a clinical trial, the regimen should include at least 4 cycles of therapy; patients who initiate planned chemotherapy but discontinue before receiving 4 cycles due to toxicity will be eligible\r\n* All planned radiation therapy and surgery for the treatment of the current cancer should be complete (not including plastic or reconstructive surgery)\r\n* Patients with local-regional recurrence without evidence of distant metastases (no definite stage IV disease) who are treated with curative intent may be eligible following completion of all surgery and/or chemotherapy and/or radiotherapy; such patients must have no evidence of residual disease by standard clinical and radiological examination (per investigator discretion) following completion of curative intent treatment
Prior non-cisplatin based neoadjuvant systemic chemotherapy for urothelial carcinoma (prior intravesical chemotherapy or immunotherapy is permissible)
Prior cisplatin based neoadjuvant systemic chemotherapy for more than 4 cycles
Women undergoing neoadjuvant chemotherapy are not eligible
For subjects receiving neoadjuvant therapy only, time between start of neoadjuvant treatment and randomization must be ? 8 weeks and subjects must be scheduled to undergo definitive treatment (including surgery and/or radiotherapy) with curative intent within approximately 9 months of starting neoadjuvant treatment
Patient who received neoadjuvant chemotherapy for ovarian cancer
Patients with muscle invasive bladder cancer (MIBC) must have never received and currently be ineligible for cisplatin-based neoadjuvant chemotherapy due to any of the following:\r\n* Calculated creatinine clearance of < 60 ml/min\r\n* Karnofsky performance status (KPS) < 80\r\n* Solitary kidney or\r\n* Patient refusal to undergo neoadjuvant chemotherapy
Neoadjuvant chemotherapy if relapse occurred at least 6 months after surgical resection;
Patient must have recovered sufficiently from any adverse effects of neoadjuvant treatment
Patient must have recovered sufficiently from any adverse effects of neoadjuvant treatment
If the subject received neoadjuvant therapy, residual tumor is present (to be determined by the primary surgeon)
Prior neoadjuvant chemotherapy or biologic therapy for current clinically or biopsy-proven node positive breast cancer within 4 weeks before the planned surgery.
Patients who will receive neoadjuvant therapy prior to definitive surgery
The subject is not a candidate for neoadjuvant chemoradiation therapy (i.e., patients with borderline resectable pancreatic ductal adenocarcinoma who are known to benefit from neoadjuvant treatment regimens)
Scheduled to undergo neoadjuvant or adjuvant chemotherapy or neoadjuvant endocrine therapy
Received neoadjuvant chemotherapy, any autoimmune or immunological disease or taking any immune suppression drugs
Planned neoadjuvant systemic therapy
Subject with neoadjuvant chemotherapy or chemoradiation
Scheduled for neoadjuvant chemotherapy and/or chemoradiation for pancreatic cancer
Subjects medically eligible for neoadjuvant cisplatin-based combination chemotherapy who refuse this therapeutic option and understand the risks and benefits of doing so.
A disposition to neoadjuvant chemotherapy with planned interval tumor reductive surgery after 4 complete cycles of treatment
Neoadjuvant chemotherapy or radiation therapy
Undergoing induction or neoadjuvant chemotherapy prior to radiotherapy
Women who are planned to receive neoadjuvant therapy
Patient did not undergo either placement of a preoperative biliary stent/drain or neoadjuvant chemotherapy with or without radiation therapy
The patient is a candidate for surgical resection, with no planned neoadjuvant chemotherapy, and there is a planned surgery for the primary colorectal cancer
Breast cancer completely excised, or patient receiving neoadjuvant therapy prior to surgery
Patient must be able to undergo stereotactic-vacuum-assisted breast biopsy with clip placement after completion of neoadjuvant chemotherapy
Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated
Patients treated with neoadjuvant hormonal therapy only are not eligible
Patients who did not undergo trimodality imaging after completion of neoadjuvant chemotherapy (breast ultrasound, MRI, and mammography)
Patients receiving neoadjuvant chemotherapy or recently completed neoadjuvant chemotherapy and will undergo surgery within 6 weeks are eligible
Prescribed neoadjuvant chemotherapy for breast cancer
Participants who enroll in a preoperative therapy trial or who have been treated with neoadjuvant chemotherapy
Women undergoing neoadjuvant chemotherapy
Patients will be treated with neoadjuvant chemoradiotherapy for this condition
Received neoadjuvant chemotherapy prior to surgical resection
Any systemic neoadjuvant (or preoperative) therapy between the core biopsy and lumpectomy
Participants who are candidates for neoadjuvant chemotherapy or neoadjuvant endocrine therapy for the treatment of newly diagnosed, invasive breast cancer
Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy
Patients must have a known site of disease; please note, for patients undergoing neoadjuvant therapy, this requirement must be met retrospectively prior to the start of neoadjuvant therapy; patients who are in radiological/clinical remission after neoadjuvant therapy, prior to infusion of radiolabeled antibody, are still eligible
Use of neoadjuvant hormonal manipulation
Be scheduled for neoadjuvant chemotherapy
Pathologically confirmed breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy
Women scheduled to receive neoadjuvant chemotherapy as part of their treatment plan
Will be receiving neoadjuvant chemotherapy for breast cancer as prescribed by their oncologist
Receiving neoadjuvant chemotherapy
Neoadjuvant chemoradiation prior to resection is planned
Neoadjuvant chemotherapy
Candidate for neoadjuvant chemotherapy
No neoadjuvant endocrine therapy or chemotherapy within 12 months
Patients diagnosed with bladder cancer with planned cystectomy and urinary diversion, +/- neoadjuvant chemotherapy
Previous chemotherapy with at least 3 cycles of docetaxel for hormone-sensitive metastatic prostate cancer
Prior treatment with docetaxel within 6 months of study enrollment
taxanes (paclitaxel or docetaxel) or epirubicin,
Docetaxel monotherapy is a reasonable treatment in the judgement of the Investigator
Prior use of abiraterone acetate, enzalutamide, docetaxel, cabazitaxel, carboplatin, or radium-223 for the treatment of castration-resistant disease\r\n* Prior docetaxel use in the hormone-sensitive disease setting is allowed, but must be completed >= 4 weeks prior to enrollment\r\n* Prior sipuleucel-T use is allowed, but must be completed >= 4 weeks prior to enrollment\r\n* Concurrent use of zolendronic acid or denosumab is allowed on study
Prior systemic chemotherapy (docetaxel, cabazitaxel, estramustine, other cytotoxic agents)
Prior treatment with docetaxel chemotherapy in the castration-resistant setting. Prior treatment with docetaxel in either the neoadjuvant or adjuvant setting or for hormone sensitive disease (e.g., CHAARTED population) is allowed, as long as therapy was completed > 12 months prior to study registration
Agree to use barrier methods of birth control during the docetaxel portion of the protocol and for at least one month after last docetaxel administration
Any previous exposure to docetaxel
Prior docetaxel for hormone-sensitive prostate cancer is permitted if =< 6 doses were given in conjunction with first-line androgen deprivation therapy and > 12 months since last dose of docetaxel
Prior treatment with docetaxel or cabazitaxel for metastatic castration-resistant prostate cancer is prohibited
Patients planned to receive docetaxel with contra-indications to receive docetaxel
Previous treatment with docetaxel for metastatic prostate cancer
Has received any prostate cancer directed chemotherapy in the castration resistant setting. Subjects who have received up to 6 prior doses of docetaxel in the castration sensitive setting are permitted if they have not experienced disease progression within 36 weeks of last treatment with docetaxel
Has known grade >= 3 docetaxel-related toxicities or docetaxel toxicity related dose interruption or discontinuation
Patients who have had chemotherapy for metastatic castration-resistant prostate cancer within the past year (patients who have had docetaxel for metastatic castration sensitive per CHAARTED data may enroll as long as they did not have progressive disease while on docetaxel and are 6 months removed from treatment, with all treatment related toxicities resolving to at least grade 1)
Chemotherapy naive (prior docetaxel chemotherapy [as per chemohormonal therapy versus androgen ablation randomized trial for extensive disease (CHAARTED) data] for castration sensitive disease is allowed)
Prior chemotherapy (e.g. docetaxel, cabazitaxel) for CRPC; prior docetaxel administered in the castrate-sensitive space is allowed
Prior treatment with ADI-PEG 20, gemcitabine, or docetaxel
Prior systemic chemotherapy (docetaxel, cabazitaxel, estramustine, other cytotoxic agents)
Prior taxane-based chemotherapy with progressive disease on chemotherapy\r\n* Prior docetaxel for metastatic hormone sensitive prostate cancer is allowed, if no progression of disease on docetaxel as defined by RECIST v1.1 and PCWG3\r\n* Prior taxane-based chemotherapy (i.e. docetaxel or cabazitaxel with or without platinum agent) for mCRPC is allowed if no progression of disease on chemotherapy as defined by RECIST v1.1 and PCWG3
Docetaxel appropriate\r\n* Patients who have not received prior docetaxel (or other taxane therapy) in the advanced setting are eligible for all cohorts\r\n* Patients who have previously received docetaxel (or other taxane therapy) in the advanced setting are eligible for the dose escalation cohort only, if anticipated to have maintained taxane sensitivity and in the opinion of the investigator would still benefit from further docetaxel therapy
Has had any previous exposure to paclitaxel or docetaxel in the last 5 years.
Radiographic progressive disease, irrespective of PSA changes, after receiving at least 4 cycles of docetaxel or cabazitaxel
Docetaxel: Creatinine clearance no minimum
Received more than 10 cycles of docetaxel (for docetaxel cohort only) or 6 of cabazitaxel (for cabazitaxel cohort only)
Last docetaxel or cabazitaxel dose > 6 weeks prior to enrollment
Progressive disease, both docetaxel naive and docetaxel treated.
Less than 6 weeks since last myelosuppressive therapy (including Docetaxel, Cabazitaxel, 223Ra, 153Sm) or other radionuclide therapy.
Prior treatment with chemotherapy (docetaxel or cabazitaxel) for castration resistant prostate cancer
A minimum of 4 weeks from prior chemotherapy, including but not limited to, docetaxel, cabazitaxel, mitoxantrone, carboplatin, cisplatin, or estramustine; if applicable, prior to registration
Previous treatment with docetaxel or an Axl inhibitor
Patients who had received at least 2 prior therapies for advanced or metastatic disease condition, including platinum doublet and pemetrexed, docetaxel, or immunotherapy, and were refractory to or unable to tolerate their last prior therapy
mCRPC EXPANSION COHORT: Patients must have received prior treatment with enzalutamide and/or abiraterone with the exception of patients who were treated with docetaxel and androgen deprivation therapy for metastatic castrate-sensitive prostate cancer and progressed on docetaxel treatment or who progress within one month of the last docetaxel dose
mCRPC EXPANSION COHORT: Patients who were treated for metastatic castrate-sensitive prostate cancer with docetaxel and androgen deprivation therapy who progress on docetaxel treatment or who progress within one month of the last docetaxel dose are eligible
Received any prior treatment with any taxane (docetaxel or paclitaxel) for small cell lung cancer
Subjects must be considered suitable for chemotherapy with either single-agent pemetrexed or docetaxel.
NSCLC that is predominantly squamous cell carcinoma, and patient had docetaxel as part of his prior chemotherapy.
Prior therapy with abiraterone, enzalutamide and/or docetaxel; if a patient has not received docetaxel or cabazitaxel chemotherapy, the patient must be informed of this treatment choice as an alternative; if the patient has received docetaxel or cabazitaxel chemotherapy or refuses one of both of these therapies, this rationale must be documented and the patient is then eligible; patient must be offered and made aware of all Food and Drug Administration (FDA)?approved treatment options; patients with bone only disease may not have received radium-223
Prior cytotoxic chemotherapy (for example, but not limited to, docetaxel, mitoxantrone, cabazitaxel) within 6 months of registration is prohibited
ARM B COHORT 2: Patients must not have prior exposure to docetaxel
ARM B COHORT 3: Patients must not have prior exposure to docetaxel
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients must have received prior treatment with enzalutamide and/or abiraterone with the exception of patients who were treated with docetaxel and androgen deprivation therapy for metastatic castrate-sensitive prostate cancer and progressed on docetaxel treatment or who progress within one month of the last docetaxel dose
PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients who were treated for metastatic castrate-sensitive prostate cancer with docetaxel and androgen deprivation therapy who progress on docetaxel treatment or who progress within one month of the last docetaxel dose are eligible
Prior treatments with Cyp 17 inhibitors like TAK-700/orteronel, ketoconazole, radium 223 or docetaxel (up to 6 cycles of docetaxel given in the non CRPC setting is allowed); prior treatment with sipuleucel-T is allowed
To commence third line docetaxel, patients must have grade 2 or less neuropathy from prior oxaliplatin treatment; also bilirubin > upper limit of normal (ULN), or AST and/or ALT > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN are not eligible for docetaxel therapy
Prior docetaxel for hormone-sensitive prostate cancer is permitted if =< 6 doses were given in conjunction with first-line androgen deprivation therapy and > 12 months since last dose of docetaxel
Prior treatment with docetaxel or cabazitaxel for metastatic castration-resistant prostate cancer is prohibited
Patients who have had prior therapy with gemcitabine or docetaxel
Prior therapy with docetaxel
No prior chemotherapy for the treatment of mCRPC; patients may have received docetaxel for the treatment of hormone-sensitive prostate cancer
Prior therapy with a MEK-inhibitor or docetaxel for metastatic non-small cell lung cancer (docetaxel in the adjuvant setting will be allowed)
No prior docetaxel or cabazitaxel chemotherapy for metastatic castration-resistant prostate cancer (mCRPC) (men treated with prior docetaxel administered as up-front therapy with androgen deprivation therapy [ADT] > 6 months ago will be eligible); prior abiraterone is allowed
Prior treatment with docetaxel or cabazitaxel for mCRPC
Prior treatment with docetaxel.
Patients must have progressed on Arm 2 (docetaxel) of this sub-study
Patients must have progressed on Arm 2 (docetaxel) of this sub-study
Patients must have progressed on Arm 2 (docetaxel) of this sub-study
Prior treatment with docetaxel is allowed but not required
Patients who are deemed to have high-risk or extensive metastatic, hormone sensitive prostate cancer (mHSPC) per “clinical judgment” of the treating physician are eligible for enrollment if they are unsuitable candidates for docetaxel or if they have declined docetaxel therapy
Prior chemotherapy (for example, docetaxel, cabazitaxel) for treatment of CRPC, except when docetaxel has been given for hormone-sensitive prostate cancer
For Cohort B: Has received prior treatment with docetaxel or another chemotherapy agent for metastatic prostate cancer
For Cohort C: Has received prior chemotherapy for mCRPC. Prior docetaxel for metastatic hormone-sensitive prostate cancer is allowed if ?4 weeks elapsed from last dose of docetaxel
Up to 6 cycles of docetaxel therapy with final treatment administration completed within 2 months of day 1 and no evidence of disease progression during or after the completion of docetaxel therapy;
Participants who received docetaxel treatment must meet the following criteria: a) Received a maximum of 6 cycles of docetaxel therapy for mHSPC; b) Received the last dose of docetaxel <=2 months prior to randomization; c) Maintained a response to docetaxel of stable disease or better, by investigator assessment of imaging and PSA, prior to randomization
Have not received prior treatment with docetaxel.
Patients who have disease progression during, or after, receiving docetaxel and have had at least 12 weeks of treatment and in the opinion of the investigator are unlikely to derive significant benefit from additional docetaxel-based therapy, or were intolerant to therapy with this agent.
Prior therapy with docetaxel for NSCLC
Prior treatment with any of the chemotherapy medications (cisplatin or docetaxel) for HNSCC or with AZD1775
Prior cytotoxic chemotherapy for prostate cancer, but up to 2 cycles of docetaxel chemotherapy for metastatic disease is permitted.
Previously received docetaxel or are not healthy enough per clinical judgment or declined to receive it
Prior cytotoxic chemotherapy with the exception of docetaxel or cabazitaxel; treatment with docetaxel or cabazitaxel must be discontinued >= 4 weeks from the time of enrollment, and recovery of adverse events (AEs) to grade 1 or baseline (however, ongoing neuropathy is permitted)
Patients must have one of the following a) low volume disease (defined as no visceral metastases and < 4 bone metastases) or b) are not candidates for docetaxel based chemotherapy or c) refused docetaxel chemotherapy
For the randomised phase only, patients must have received chemotherapy in the form of docetaxel treatment for metastatic castration-resistant prostate cancer. Note: patients who discontinued docetaxel for toxicity reasons and without completing the full course will still be eligible to enter this study provided they received at least 2 cycles of chemotherapy.
Prior disease progression on docetaxel or paclitaxel in metastatic setting
Participants may have received prior docetaxel-based chemotherapy for prostate cancer; such chemotherapy must have been stopped at least three weeks prior to the first dosing in this study
Patients who have had chemotherapy for metastatic castration-resistant prostate cancer; (patients who have had docetaxel for metastatic castration sensitive disease per ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer [CHAARTED] Data may enroll as long as they did not have progressive disease while on docetaxel and are 6 months removed from treatment, will all treatment related toxicities resolving to at least grade 1)
Prior cytotoxic chemotherapy (e.g. docetaxel, mitoxantrone, cabazitaxel) within 6 months of registration is prohibited
The subject has had treatment with docetaxel for the treatment of metastatic castrate-sensitive prostate cancer within 6 months before the first dose of study treatment
The subject has had progression of prostate cancer during 6 cycles of prior docetaxel treatment for castrate sensitive disease
Prior treatment with Docetaxel
Prior therapy with pazopanib, gemcitabine or docetaxel; patients who have had prior treatment with gemcitabine or docetaxel for a prior malignancy are eligible if they meet the criteria in exclusion #3 and did not experience significant drug related toxicity
Planned or recent initiation of standard docetaxel therapy; patients may be enrolled after receiving standard docetaxel therapy as long as the patient has not demonstrated evidence of progression for more than 45 days before enrollment (“late enrollers”)
Known hypersensitivity to docetaxel, fluorouracil (5-FU)
Patients who have received previous docetaxel or cisplatin
Prior treatment with docetaxel-based chemotherapy
Prior treatment with docetaxel within 6 months of enrollment
Previous treatment with docetaxel.
Hypersensitivity to the active substance or ingredients of PEGPH20 and docetaxel.
Received prior treatment with docetaxel.
Patients receiving chemotherapy (e.g., docetaxel, cabazitaxel, taxane, or platinum as single agents or in combination) as their cancer treatment
Patient must be eligible for chemotherapy with docetaxel
Symptomatic patients who, in the opinion of the investigator, may benefit from docetaxel-based chemotherapy
Prior treatment with docetaxel or mogamulizumab;
Prior treatment with docetaxel
Prior docetaxel or other chemotherapy for mCRPC; patients who have received docetaxel for metastatic hormone-sensitive prostate cancer are eligible
Prior treatment with MLN4924; however, prior treatment with docetaxel, paclitaxel, and carboplatin is allowed.
Prior treatment with docetaxel for recurrent or advanced NSCLC
Prior treatment with docetaxel-containing therapy
Participants with NSCLC to be treated with docetaxel need to have received at least one prior anti-cancer treatment regimen in an advanced setting and to have docetaxel be considered appropriate treatment
Received prior docetaxel chemotherapy
Part 2 only: Patients must be docetaxel-naive.
Part 2 only: Patients may not have had prior treatment with docetaxel.
History of treatment with docetaxel in any setting. Participants treated with prior paclitaxel are eligible.
Prior treatment with docetaxel-based chemotherapy
Patients who have received docetaxel plus anti-androgen therapy (ADT) for metastatic castrate sensitive prostate cancer are eligible for the study; (patients may enroll as long as they did not have progressive disease while on docetaxel and are 6 months removed from treatment, with all treatment related toxicities resolving to at least grade 1)
Have had treatment with docetaxel for the treatment of metastatic castrate-sensitive prostate cancer within 6 months before the first dose of study enrollment
Have had progression of prostate cancer on prior docetaxel treatment for castrate sensitive disease
Patients with prior docetaxel chemotherapy
Pain appeared during or up to 12 weeks after treatment with oxaliplatin, paclitaxel, docetaxel or any combination of these
Have metastatic castration-resistant prostate cancer (prostate cancer progressing despite castrate levels of testosterone [< 50 ng/dL] using standard measures of progression defined by Prostate Cancer Working Group 2), are chemo-naive for metastatic castration-resistant prostate cancer (mCRPC); patients must have symptomatic disease or visceral metastases or otherwise be eligible for docetaxel treatment per investigator judgment (e.g. for progression on imaging or rapidly rising PSA despite 2nd line hormonal treatment);\r\n* Note: Six cycles of prior docetaxel are allowed in hormone-sensitive disease, per Eastern Cooperative Oncology Group (ECOG) 3805 data and have been off of docetaxel for at least 12 months
Undergoing current therapy for organ confined or systemic disease; this does not preclude patients who had previously received upfront docetaxel in the hormone sensitive setting
Prior docetaxel-based chemotherapy is permitted but not required
No prior immunotherapy for advanced/metastatic MCC
Have not received prior anti-cancer therapy for advanced or metastatic melanoma
Diagnosed with advanced or metastatic malignancy
For Part A dose confirmation: All participants must have histological evidence of advanced or metastatic soft tissue sarcoma or breast cancer. Breast cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
For Part B dose confirmation: All participants must have histological evidence of advanced or metastatic colon cancer or soft tissue sarcoma. Colon cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
For Part C dose confirmation: All participants must have histological evidence of advanced or metastatic breast cancer and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
For Part E dose confirmation: All participants must have histological evidence of locally advanced or metastatic triple negative breast cancer (TNBC) and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway. Participants must not have received >2 lines of systemic treatment for advanced or metastatic TNBC.
Diagnosis of metastatic or advanced CRC, UCC, SCCHN, salivary gland cancer or NSCLC with tumor accessible for biopsy
Incurable advanced solid tumors that are no longer responding to conventional therapy or for which no effective therapy exists; at the RD of Part 1, an extension cohort up to 20 patients with metastatic breast cancer who are known to be BRCA mutation carriers will be enrolled.
During Phase 2, subjects with advanced cancer who have received at least one prior therapy or are treatment naive, depending on the specified tumor type.
Cohort 1: advanced breast cancer, ISH positive or IHC 3+.
Cohort 2: advanced breast cancer, ISH negative with IHC 2+.
Have advanced or metastatic cancer (solid tumors) and be an appropriate candidate for experimental therapy.
Part B2: Have advanced/metastatic cancer carrying activating mitogen-activated protein kinase (MAPK) pathway alteration
Parts A, A2 & B1: Participants must have pathological evidence of a diagnosis of advanced and/or metastatic cancer and must be, in the judgment of the investigator, an appropriate candidate for experimental therapy
Advanced myelofibrosis
Advanced measurable malignancy
Advanced Gastric Cancer
Patients must have pathologically confirmed advanced/metastatic cancer prior to enrollment.
Self-identified Black, African or African American women with proven diagnosis of advanced breast cancer (locoregionally recurrent or metastatic disease), either from the primary or a metastatic site
To be eligible for Cohort 5, patients must not have received any systemic therapy for advanced/metastatic disease
For the dose escalation phase, patients must have histologically confirmed metastatic solid tumor (metastatic or unresectable, locally advanced gastrointestinal [GI] cancers [e.g., esophageal, colorectal, pancreatic and others]), ovarian and breast cancers; the malignancy should be considered incurable using standard treatment; for the extension cohort (N=12) and for the expansion phase (N=45), patients with advanced breast cancer (N=15), advanced gastrointestinal cancer (N=15) and advanced ovarian (N=15) will be enrolled; all patients enrolled on the extension and expansion phase will be required to have measurable disease
Advanced myelofibrosis
Has a pathologically documented advanced/unresectable or metastatic breast cancer
All parts except Part B, Part E2, and Part E3 dose expansion: Must have diagnosis of cancer that is advanced or metastatic
Part E2 dose expansion: must have cancer that is advanced or metastatic and have prior documentation of a mutation of PIK3CA
Progressed after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer
Patient has confirmed HER2-negative advanced breast cancer (aBC)
Diagnosis of advanced stage or metastatic HER2-positive cancer with disease progressed after receiving at least one prior systemic therapy (immunohistochemistry or RT-PCR is used to determine HER2 positivity)
For Phase 1: Subjects who have advanced or metastatic disease as noted above that have received at least one prior therapy or have advanced or metastatic disease for which no curative treatment is available may be enrolled.
Phase 2: Subjects with advanced or metastatic endometrial cancer, gastric cancer (including stomach, esophageal, and GEJ), and SCCHN.
Inclusion Criteria:\n\n        Among other criteria, patients must meet all of the following conditions to be eligible for\n        the study:\n\n          1. Diagnosed with metastatic (i.e., cancer that has spread) TNBC\n\n               -  minimal or no expression of estrogen and progesterone receptors (ER/PR) <10% of\n                  cells positive by immunohistochemistry\n\n               -  HER 2 staining 0 or 1+ by IHC or copy number <4.0 signals/cell\n\n          2. Documented progression of disease based on radiographic, clinical or pathologic\n             assessment during or subsequent to the last anticancer regimen received.\n\n          3. Breast cancer tumor confirmed to express gpNMB. This will be determined by submitting\n             a tissue sample from the advanced (locally advanced/recurrent or metastatic) disease\n             setting to a central laboratory for analysis.\n\n          4. Received no more than two prior chemotherapy treatments for advanced (locally\n             advanced/recurrent or metastatic) breast cancer.\n\n          5. Prior chemotherapy treatment must have contained an anthracycline (e.g. doxorubicin or\n             Doxil) if clinically indicated and a taxane (eg: Taxol).\n\n          6. ECOG performance status of 0 - 1.\n\n          7. Adequate bone marrow, liver and renal function.\n\n        Exclusion:\n\n        Among other criteria, patients who meet any of the following conditions are NOT eligible\n        for the study:\n\n          1. Progression/recurrence of breast cancer during or within 3 months of completion of\n             neoadjuvant or adjuvant chemotherapy.\n\n          2. Ongoing neuropathy or other chemotherapy or radiation-related toxicities that are\n             moderate (Grade 2) or worse in severity.\n\n          3. Known brain metastases, unless previously treated and asymptomatic for 2 months and\n             not progressive in size or number for 2 months.\n\n          4. Significant cardiovascular disease.\n\n          5. Previously received capecitabine and discontinued due to progression or intolerance;\n             previously received CDX-011 or other MMAE containing agents.\n\n          6. Active systemic infection requiring treatment. Infection controlled by oral therapy\n             will not be exclusionary.\n\n          7. Chronic use of systemic corticosteroids.
For Part B: All participants must have a histological evidence of their advanced or metastatic cancer and prescreened alterations in a defined pathway.
For Part D: All participants must have histological evidence of advanced or metastatic cancer and prescreened alterations in a defined pathway.
Radiologic/objective evidence of breast cancer recurrence or progression while on or within 12 months of the end of adjuvant treatment with an AI, or progression while on or within 1 month of the end of prior AI treatment for locally advanced or metastatic breast cancer
Patients who received more than one chemotherapy line for advanced breast cancer.
newly diagnosed advanced/metastatic breast cancer at diagnosis that progressed with documented evidence of progression after one line of endocrine therapy (with either an antiestrogen or an aromatase inhibitor)
Patients who received any prior hormonal anti-cancer therapy for advanced breast cancer, except for ? 14 days of tamoxifen or NSAI ± goserelin for advanced breast cancer prior to randomization.
Advanced measurable malignancy
Participants with radiologic/objective evidence of breast cancer recurrence or progression while on or within 6 months after the end of adjuvant treatment with an AI, or progression while on or within 1 month after the end of prior AI treatment for locally advanced or metastatic breast cancer
Advanced or metastatic cancer
Part D: Breast cancer that is advanced and/or metastatic
Part E: Melanoma that is advanced and/or metastatic
Has had previous therapy for advanced/metastatic adenocarcinoma or squamous cell cancer of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the EGJ
Histologically confirmed advanced or metastatic non-curable solid tumor (if limited to a single lesion may not be a candidate for curative surgery or radiation therapy). Successful vaccine manufacture has resulted from tissue/fluid obtained from the following major organ systems: digestive, endocrine, reproductive, respiratory, and urinary.Individuals manufactured under CL-PTL 105 (Phase II Ovarian) may be eligible for enrollment without advanced or metastatic disease.
Confirmed diagnosis of: \r\n* Postmenopausal advanced hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer after failure of treatment with letrozole or anastrozole\r\n* Progressive neuroendocrine tumors of pancreatic origin (PNET) that is unresectable, locally advanced or metastatic\r\n* Advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib
Initial diagnosis of advanced stage disease must have occurred ? 6 weeks prior to starting Cycle 1 Day 1. NOTE: The clock for this time interval starts with the date of last evaluation confirming advanced disease (either biopsy or imaging results).
Received prior treatment with capecitabine or fluoropyrimidine for advanced or metastatic disease
Previous systemic therapy for advanced or metastatic disease.
With advanced breast cancer whose disease was refractory to previous letrozole or anastrozole
Have advanced or metastatic cancer and be an appropriate candidate for experimental therapy.
Advanced cervical or endometrial cancer, T3/T4 lesions
Prior or concomitant treatment for advanced breast cancer.
Have advanced or metastatic cancer and be an appropriate candidate for experimental therapy.
Metastatic or advanced breast cancer that is evaluable OR metastatic or advanced breast cancer that is measurable for response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Histologically or cytologically confirmed: solid malignancy or lymphoma that is metastatic or unresectable, and for which standard curative treatment is no longer effective (Part 1); any type of advanced or refractory solid malignancy (excluding lymphoma) that is metastatic or unresectable and for which standard curative treatment is no longer effective (Part 2); advanced or refractory squamous non-small cell lung cancer (Cohort A, Part 3), advanced or refractory small cell lung cancer (Cohort B, Part 3), advanced or refractory breast cancer (Cohort C, Part 3), any type of advanced or refractory solid malignancy (excluding lymphoma) ([consisting of one of the following: gastric, head and neck, lung adenocarcinoma, urothelial, glioblastoma multiforme (GBM), ovarian or prostate]) (Cohort D, Part 3), advanced or refractory non small cell lung cancer(Cohort E, Part 4), any type of advanced or refractory solid malignancy (consisting of one of the following: Breast, Urothelial, GBM, Ovarian, Head & Neck, Esophageal, Gastric, and Cholangiocarcinoma) (Cohort F, Part 4)
Dose Escalation Phase: Patients with advanced or metastatic solid tumors for which no standard therapy is available. For Schedule 6 only: patients with colorectal cancer with liver metastasis. Dose Expansion Phase: Previously treated, metastatic or advanced recurrent malignancy with 1 of the following diagnoses, which has been confirmed histologically or cytologically:
Patients with advanced cutaneous or subcutaneous in-transit or metastatic melanoma
Has received prior capecitabine treatment for advanced breast cancer
Diagnosis of an advanced solid tumor malignancy (advanced cancer) or lymphoma; in most situations, this would be a stage IV cancer; patients with a diagnosis of stage III cancer or lymphoma are eligible if cure is not possible or anticipated; clinical staging without pathological confirmation of advanced disease is allowed
Men and women with recurrent or advanced breast cancer
Key Inclusion Criteria\n\n        All Study Parts:\n\n          -  Diagnosis of cancer that has been histologically or cytologically confirmed\n\n          -  Eastern Cooperative Oncology Group Performance Status of 0 or 1\n\n        Part A (1 of the following):\n\n          -  Ovarian cancer, triple-negative breast cancer, head and neck squamous cell cancer,\n             bladder cancer, metastatic colorectal cancer, pancreatic ductal adenocarcinoma, or\n             gastric cancer that is measurable or evaluable, nonmeasurable as defined by RECIST\n             v1.1 and meets 1 of the following criteria:\n\n               -  is refractory to standard of care\n\n               -  no standard therapy available\n\n               -  patient refuses standard therapy\n\n          -  Advanced, unresectable, or metastatic melanoma with or without prior treatment and\n             measurable or evaluable, nonmeasurable disease as defined by RECIST v1.1\n\n          -  Advanced/metastatic PD-L1-positive NSCLC (defined as a tumor proportion score [TPS] ?\n             50%) with measurable or evaluable, non-measurable disease as defined by RECIST v1.1 (1\n             of the following):\n\n               -  1) No prior systemic chemotherapy if tumor does not have EGFR or ALK genomic\n                  aberrations\n\n               -  2) Disease progression on or after platinum-containing chemotherapy;\n\n               -  3) If tumor has EGFR or ALK genomic aberrations, disease progression on an\n                  FDA-approved therapy for EGFR or ALK genomic tumor aberrations\n\n        Phase 2 (1 of the following):\n\n          -  Advanced/metastatic solid tumor with PD as defined by RECIST 1.1 or irRC on an\n             anti-PD-1- or anti-PD-L1-containing regimen as their most recent prior therapy\n\n          -  Advanced/metastatic epithelial ovarian cancer, peritoneal cancer or tubal cancer with\n             measurable disease as defined by RECIST 1.1, that had progressed within 6 months of\n             completing ? 4 cycles of platinum-based therapy\n\n          -  Advanced/metastatic PDA that is locally advanced, unresectable or metastatic with\n             measurable disease as defined by RECIST v1.1 in patients who have received at least\n             one prior line of systemic therapy for their disease\n\n        Key Exclusion Criteria\n\n          1. Prior treatment as follows:\n\n               -  Part A: an immune CPI (e.g., PD-1, PD-L1, or cytotoxic T-lymphocyte antigen 4\n                  [CTLA-4] inhibitor).\n\n             NOTE: For patients with melanoma, prior treatment with ipilimumab is allowed if it was\n             administered as adjuvant therapy and treatment was completed at least 3 months prior\n             to enrollment.\n\n               -  Phase 2:\n\n                    -  A CSF-1R inhibitor or CSF-1 (or MCSF) inhibitor.\n\n                    -  prOVCA and PDA patients only: an immune CPI (e.g., PD-1, PD-L1, or CTLA-4\n                       inhibitor)\n\n          2. Symptomatic brain metastasis at screening\n\n          3. Active autoimmune disease, documented history of autoimmune syndrome or disease, or a\n             chronic medical condition that requires chronic steroid therapy or immunosuppressive\n             medication\n\n          4. History of pneumonitis or interstitial lung disease\n\n          5. Severe, acute, or chronic medical or psychiatric condition or laboratory abnormality\n             that may increase the risk associated with study participation or study drug\n             administration or that may interfere with the interpretation of study results and, in\n             the judgment of the Investigator, would make the patient an inappropriate candidate\n             for the study\n\n          6. Ocular melanoma
Advanced or metastatic breast cancer
(Patient participation) Diagnosis of advanced cancer
Advanced, incurable cancer
Patient with a diagnosis of advanced cancer (metastatic or recurrent incurable solid tumors excluding prostate cancer)
A new diagnosis (within 3 months) of advanced cancer and/or patients receiving ongoing care from a medical oncologist (solid tumors) or a new recurrence of the primary cancer in an advanced stage
A diagnosis of advanced cancer (defined as metastatic or recurrent) with fatigue >= 4/10 (0-10 scale) on the Edmonton Symptom Assessment Scale (ESAS)
Definition of advanced cancer includes those patients who have metastatic or refractory disease according to their treating oncologist
Diagnosis of an advanced solid tumor malignancy (advanced cancer) or lymphoma; in most situations, this would be a stage IV cancer; a patient with a diagnosis of stage III cancer or lymphoma is eligible if cure is not possible or anticipated; clinical staging without pathological confirmation of advanced disease is allowed
Subjects must have histologic documentation of advanced recurrent or metastatic cancer.
Diagnosis of advanced (metastatic or recurrent) lung, breast, colorectal, prostate, or gynecological (GYN), or other solid tumor cancer; the symptom cluster of pain, fatigue, and sleep disturbance is common in these patients
Unresectable advanced or metastatic ACC, non-urothelial bladder/upper tract cancer, non-adenocarcinoma prostate cancer, penile cancer or treatment refractory germ-cell tumor
No findings in the rectum of advanced adenoma, chronic inflammation, or cancer
Advanced periodontal disease (gum disease)
Subject has been diagnosed with an advanced solid malignancy; advanced solid malignancy is defined as loco regional or systemic metastatic disease of at least 1 cm in diameter; tumor types allowed include: triple negative breast, prostate, colorectal, gastric, ovarian, pancreatic, esophageal, soft tissue sarcoma, and head & neck cancer; subjects with primary or metastatic skin disease only are excluded from participation in this study
Confirmed diagnosis of advanced, refractory breast or prostate cancer that is evaluable by radiologic testing. Participants must have experienced tumor progression on or treatment intolerance to at least one prior therapy.
Oncologists who do not have enough patients with advanced cancer
Inclusion Criteria:\n\n        All subjects:\n\n          -  Pathologically confirmed diagnosis of solid tumors\n\n          -  Metastatic disease\n\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1\n\n          -  Adequate bone marrow, hepatic and renal function\n\n          -  Normal Electrocardiogram (ECG)\n\n          -  18 years of age or above\n\n          -  Able to understand and sign informed consent\n\n        Pilot study only:\n\n        - CRC, TNBC, ER/PR Breast Cancer, NSCLC, Pancreatic Cancer, Ovarian Cancer, Gastric Cancer,\n        Gastroesophageal Junction (GEJ) adenocarcinoma, Head and Neck Cancer\n\n        Expansion Phase Additional Criteria:\n\n          -  Locally advanced or metastatic breast cancer\n\n          -  Received at least one cytotoxic therapy in the locally advanced and metastatic setting\n\n          -  Received ? 5 prior lines of chemotherapy in the metastatic setting\n\n          -  Candidate for chemotherapy\n\n        Expansion Phase Cohort 3 additional inclusion criteria:\n\n          -  Breast cancer with active brain metastasis\n\n          -  Neurologically stable\n\n        Exclusion Criteria:\n\n          -  Active Central nervous system (CNS) metastasis (applies to pilot phase and expansion\n             phase cohort 1 and 2 only)\n\n          -  Clinically significant GI disorders\n\n          -  Prior irinotecan or bevacizumab therapy within last 6 months and for Expansion Phase\n             patients, have received any prior treatment with Topol inhibitor\n\n          -  Known hypersensitivity to MM-398 or ferumoxytol\n\n          -  Inability to undergo MRI\n\n          -  Active infection\n\n          -  Pregnant or breast feeding\n\n          -  Prior chemotherapy administered within 3 weeks, or within a time interval less than at\n             least 5 half-lives of the agent, whichever is longer, prior to the first scheduled day\n             of dosing in this study\n\n          -  Received radiation therapy in the last 14 days\n\n          -  Treated with parenteral iron in the previous 4 weeks
SCLC or PAC that is advanced or has spread to other parts of the body