History of other malignancy that could affect compliance with the protocol or interpretation of results
Any medical condition or laboratory test abnormality that precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results
History of other malignancy that could affect compliance with the protocol or interpretation of results
Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results
History of other malignancy that could affect compliance with the protocol or interpretation of results
Have a second primary malignancy that in the judgment of the investigator or Lilly may affect the interpretation of results.
Have known acute or chronic leukemia or current hematologic malignancies (except iNHL for patients in Part B5) that, in the judgment of the investigator and sponsor, may affect the interpretation of results
Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results (Part B only)
History of other malignancy that could affect compliance with the protocol or interpretation of results
A second primary malignancy that in the judgment of the principal investigator (PI) or designee may affect the interpretation of results
History of other malignancy that could affect compliance with the protocol or interpretation of results
History of other malignancy that could affect compliance with the protocol or interpretation of results
History of other malignancy, autoimmune disease, or any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results
History of other malignancy that could affect compliance with the protocol or interpretation of results
History of other malignancy that could affect compliance with the protocol or interpretation of results
History of other malignancy, which could affect compliance with the protocol or interpretation of results
Second primary malignancy that may affect the interpretation of results
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
History of other malignancy that could affect compliance with the protocol or interpretation of results
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
Have a second primary malignancy that in the judgment of the investigator and Medical Monitor may affect the interpretation of results.
Have known acute or chronic leukemia or current hematologic malignancies that, in the judgment of the investigator and sponsor, may affect the interpretation of results.
Have a second primary malignancy that in the judgment of the investigator and medical monitor may affect the interpretation of results.
Have a second primary malignancy that, in the judgment of the investigator and sponsor, may affect the interpretation of results.
Have a second primary malignancy that, in the judgment of the investigator and sponsor, may affect the interpretation of results. Curatively treated nonmelanoma skin cancer or in situ carcinoma of any origin is allowed.
History of other malignancy that could affect compliance with the protocol or interpretation of results
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or that could increase risk to the participant
- Evidence of any significant disease or condition that could affect compliance with the protocol or interpretation of results.
Have second primary malignancy that may affect the interpretation of results.
Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results
Patients with a second malignancy that might interfere with interpretation of the results of this study
Significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
Patient must not have a concurrent active malignancy for which they are receiving treatment
Presence of concurrent non-solid malignancy
Patients with concurrent malignancy except for nonmelanoma skin lesions
Previous or concurrent additional malignancy
Patient must not have a concurrent active malignancy for which they are receiving treatment
Patients with a concurrent active malignancy under treatment.
Presence of any other concurrent active malignancy
Concurrent active malignancy that requires systemic treatment
The presence of any other concurrent active malignancy
DONOR: Concurrent malignancy or autoimmune disease
Patient has a concurrent active malignancy under treatment
Concurrent active malignancy of another type
Patients with concurrent malignancy except for nonmelanoma skin lesions
Concurrent malignancy or history of other malignancy within the last five years except as noted above
Other active, concurrent malignancy that requires ongoing systemic treatment or interferes with radiographic assessment of melanoma response as determined by the investigator.
Patients must not have a concurrent active malignancy for which they are receiving treatment
Patient has a concurrent advantage active malignancy under treatment
Is being actively treated for another concurrent malignancy or is less than five years from completion of treatment for another malignancy
The participant has a concurrent active malignancy other than the following:
Previous or concurrent malignancy with the following exceptions:
Have a previous malignancy within 5 years of study entry or a concurrent malignancy.
DONOR: Concurrent malignancy or autoimmune disease
Other active, concurrent malignancy that requires ongoing systemic treatment or interferes with radiographic assessment of melanoma response as determined by the investigator
Prior or current malignancy that does not require concurrent treatment;
Subject has been diagnosed with another malignancy that requires concurrent treatment or hepatic malignancy regardless of need for treatment.
Patient has a concurrent active malignancy under treatment
Any concurrent and/or other active malignancy that has required treatment within 2 years of first dose of study drug.
Patients must not have other active concurrent malignancy
Concurrent malignancy diagnosed within 6 months of entry to the study
Patients with a concurrent malignancy
Concurrent or prior malignancy except for the following:
Concurrent other malignancy
Donor does not have concurrent malignancy or autoimmune disease
Donor has evidence of concurrent malignancy or autoimmune disease
Concurrent malignancy other than SCLC. History of other malignancy is allowed as long as there is no evidence of active disease or need for treatment.
Patients with active concurrent malignancy, other than superficial, non-invasive squamous cell carcinoma of the skin or uterine cervix, within the past three years; an active concurrent malignancy will be defined as one currently requiring cancer-directed treatment, or deemed by the treating physician as likely to require such treatment within a six-month period from time of screening
Patients with a concurrent active malignancy (with the exception of skin cancer)
Cholangiocarcinoma with extra-hepatic metastasis or concurrent non-solid malignancy
Patients with concurrent malignancy; patients with prior or concurrent malignancy will be allowed as long as the treating physician considers it unlikely to impact the clinical outcome of the patient
Patients with known concurrent malignancy
Active concurrent malignancy (except skin cancer)
Concurrent active malignancy under treatment.
Uncontrolled concurrent malignancy
Being actively treated for another concurrent malignancy
Another active concurrent malignancy.
Uncontrolled concurrent malignancy that would limit assessment of efficacy of cabozantinib
Concurrent malignancy or malignancy within 3 years prior to start of study treatment
Patient has another concurrent invasive malignancy (aside from the malignancy for which the patient has received therapy for on the parental protocol).
Concurrent active malignancy.
Presence of another concurrent malignancy requiring treatment
Previous or concurrent malignancy is not an exclusion provided that the other malignancy is considered under control and target lesions from melanoma are clearly defined for response assessment
Evidence of other concurrent active malignancy
Patients must not have other active concurrent malignancy
Current severe active systemic disease including active concurrent malignancy
Presence of any other concurrent, actively treated malignancy
Presence of a concurrent, actively treated malignancy
Concurrent or history of malignancy
Participants must not have any other concurrent malignancy
Patients have a concurrent malignancy
Patient must not have another active (within past 3 years) or concurrent malignancy
Concurrent malignancy other than skin cancer
Presence of concurrent non-solid malignancy
Prior or concurrent malignancy, except the following:
Participants with other active malignancy requiring concurrent intervention
Other active malignancy requiring concurrent intervention
Subjects with other active malignancy requiring concurrent intervention
Other active malignancy that is progressing, requires concurrent intervention, and/or could be mistaken for the malignancy under study during disease assessments
Concurrent active malignancy requiring immediate therapy
Pts receiving active treatment or intervention for any other malignancy or pts who, at the Investigator's discretion, may require active treatment or intervention for any other malignancy within 8 months of starting study treatment.
Participants with other active malignancy requiring concurrent intervention
Participants with any other active malignancy requiring concurrent intervention
Uncontrolled concurrent malignancy (early stage is allowed if not requiring active therapy or intervention)
Active concurrent malignancy requiring active therapy
Participants with other active malignancy requiring concurrent intervention
Other active malignancy requiring concurrent intervention
Participants must not have other active malignancy requiring concurrent intervention
Other active malignancy requiring concurrent intervention.
Concurrent malignancy requiring cytotoxic or immunotherapy based treatment
Other active malignancy requiring concurrent intervention; a history of prior malignancy will not be an exclusion factor as long as the patient is not currently requiring treatment for this malignancy
Diagnosed with another concurrent malignancy requiring treatment
Other active malignancy requiring concurrent intervention
Patients receiving active treatment or intervention for any other malignancy or patients who, at the investigator’s discretion, may require active treatment or intervention for any other malignancy within 8 months of starting study treatment
Concurrent malignancy requiring active therapy
Other active malignancy requiring concurrent intervention
Concurrent malignancy other than the solid tumor under investigation, requiring\n active treatment.
Subject has another active malignancy requiring concurrent intervention;
Other active malignancy requiring concurrent intervention
Concurrent malignancy requiring active therapy \r\n* Patients with more than one type of lymphoma may be enrolled after discussion with the MSK principal investigator
Patient has an active concurrent malignancy requiring active therapy
Active concurrent malignancy requiring active therapy
Active concurrent malignancy requiring active therapy
Concurrent active malignancy requiring immediate therapy
An active malignancy that requires concurrent intervention
Concurrent active malignancy requiring immediate therapy
Concurrent active malignancy other than AML requiring therapy
Concurrent active malignancy requiring systemic treatment
No concurrent malignancy with a life expectancy of less than two years, or one that requires ongoing chemotherapeutic intervention at screening
Patients receiving active treatment or intervention for any other malignancy or patients who, at the Investigator's discretion, may require active treatment or intervention for any other malignancy within 8 months of starting study treatment.
Patient has an active concurrent malignancy requiring active therapy
Concurrent malignancy requiring active treatment with chemotherapy, immunotherapy, or radiation
Known history of another primary malignancy that has not been in remission for ?1 year
In patients with a prior history of invasive malignancy, less than five years in complete remission
Patients with a history of any other malignancy, except patients with a secondary brain tumor if the patient’s first malignancy has been in remission for at least 5 years from the end of treatment
History of another primary malignancy that has not been in remission for at least 2 years.
Subjects must be in primary remission
Second primary invasive malignancy that has not been in remission for greater than 2 years.
Subjects who have an uncontrolled systemic malignancy that is not in remission
History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 1 year
History of another invasive malignancy that has not been in remission for at least 3 years
A primary malignancy which has been completely resected and in complete remission for ? 5 years
Known history of another primary malignancy that has not been in remission for ?2 years
History of a primary invasive malignancy not listed in the inclusion criteria, which has not been in remission for at least 3 years. The following are exempt from the 3 year limit:
History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years
other effectively treated malignancy that has been in remission for more than 5 years and is considered to be cured
Patients with another primary malignancy that has not been in remission for at least 3 years.
History of another primary invasive malignancy that has not been in remission for at least 3 years
Patients who have had a previous malignancy that is not in remission
Participants with history of another primary malignancy not in remission for at least 3 years
Patients who have had a previous malignancy that is not in remission
Second primary malignancy that has not been in remission for greater than 3 years. Exceptions that do not require a 3 year remission include: related non-melanoma skin cancer or resected melanoma in situ.
History of another primary malignancy that has not been in remission for at least 3 years
Prior malignancy (excluding nonmelanoma carcinomas of the skin) unless in remission for 2 years.
History of a concurrent or second malignancy, except for specified exceptions in the protocol or any other cancer that has been in complete remission for ? 5 years
the malignancy has been in remission without treatment for ? 5 years prior to enrollment, or
History of another primary malignancy that has not been in remission for 3 years
Second primary malignancy that has not been in remission for more than 3 years
History of another primary malignancy that has not been in remission for at least 3 years
Has history of a diagnosed and/or treated hematologic or primary solid tumor malignancy, unless in remission for at least 5 years prior to randomization
Subject has other prior malignancy that is not in complete remission.
Second primary invasive malignancy that has not been in remission for greater than 2 years.
No currently active other malignancies which require systemic treatment
Patients with previous malignancies that have been treated with systemic chemotherapy with alkylator or anthracycline therapy. The latter group of patients are excluded due to an expected increase in late effects (eg. late cardiac toxicity, secondary malignancies, sterility, etc.).
Subjects with any of the following solid malignancies:
Have other active malignancies or diagnosed with other malignancies within the last 6 months, except nonmelanoma skin cancer or cervical intraepithelial neoplasia
Have prior malignancies. Participants with carcinoma in situ of any origin and participants with prior malignancies who are in remission and whose likelihood of recurrence is very low, as judged by the Lilly clinical research physician, are eligible for this study.
Patients with other active malignancies are ineligible for this study, other than localized malignancies
Other active malignancies.
Research participants with any other active malignancies
Other malignancies requiring active treatment in the last 6 months
Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin
Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin
Natural Killer cell malignancies
Natural killer cell malignancies
Concurrent, clinically significant, active malignancies within 12 months of study enrollment
Any concurrent active malignancies, defined as malignancies requiring any therapy other than expectant observation, since adverse events resulting from these malignancies or their treatment may confound our assessment of the safety of adoptive T cell therapy for ovarian cancer
Patients with a history of other malignancies, except:
Patients with multiple malignancies remain eligible
Research participants with any other active malignancies
Patients with other active malignancies are ineligible for this study, other than localized malignancies
Other active malignancy (other than malignancies, which the investigator determines are unlikely to interfere with treatment and safety analysis)
Concurrent malignancies
Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation
Have other active malignancies or diagnosed with other malignancies within the last 6 months, except nonmelanoma skin cancer or cervical intraepithelial neoplasia
Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation
Natural killer cell malignancies
Natural killer cell malignancies
Other untreated coexisting HIV related malignancies.
Other concomitant active malignancies
History of other active malignancies.
EXCLUSION FOR COLLECTION OF T CELLS/PBMCS: Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation
EXCLUSION FOR TREATMENT: Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation
Patients with other active malignancies (no evidence of other cancer or life expectancy greater than 5 years) are ineligible for this study
Known other active malignancy (other than malignancies which the investigator determines are unlikely to interfere with treatment and safety analysis)
Patients with other malignancies or brain metastasis are not eligible; however, given the frequent coexistence of MCC with other malignancies, the following exceptions are allowed:
Other active malignancies
Other malignancies requiring active therapy or known to be associated with altered immune response
Previous malignancies
Patients with active (uncontrolled, metastatic) second malignancies are excluded.
Relapsed disease or development of other malignancies
Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation, with the exception of squamous and basal cell carcinoma of skin
Most concurrent second malignancies
Concurrent, clinically significant, active malignancies within two years of study enrollment.
History of any other active malignancies
Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation
History of other malignancies, except:
History of other malignancies, except
Other active malignancies
Subjects may not have other active malignancies other than indolent malignancies not requiring active therapy which the investigator determines are unlikely to interfere with treatment and safety analysis
Patients with other active malignancies (no evidence of other cancer or life expectancy greater than 5 years) are ineligible for this study
Other concurrent malignancies except skin cancer
All gastrointestinal malignancies where the patient received oxaliplatin for cancer treatment or breast malignancies where patients have received docetaxel or paclitaxel for cancer treatment
Patients with a new suspected or confirmed gynecologic malignancies
Natural Killer Cell Malignancies
Prior malignancies.
Patient with salivary gland malignancies
Relapsed or progressive advanced malignancies (solid tumors or hematologic malignancies)
Participants may not have a second, clinically active, cancer; patients with second cancers which have been treated with curative intent and/or are currently inactive are allowed
Active second malignancy requiring treatment or that would interfere with assessment of response of the lymphoma per investigator’s discretion
Second malignancy currently requiring active therapy (except for hormonal/antihormonal treatment, e.g. in prostate or breast cancer).
Second primary malignancy that requires active therapy. Adjuvant hormonal therapy is allowed.
Phase 2 only: second malignancy within the last 3 years.
Participants with an active second malignancy
Active second malignancy.
Presence of concurrent second cancer (active, not history)
Active concurrent second malignancy.
Patients with a second, clinically active, cancer; patients with second cancers which have been treated with curative intent and/or are currently inactive are allowed
Second invasive malignancy requiring active treatment
Metastatic disease or currently active second malignancy
Second primary malignancy
Active second malignancy or other prior malignancy treated with chemotherapy less than or equal to 6 months prior to treatment with CK-101
History of a second malignancy, excluding non-melanoma skin cell cancer within the last three years. Subjects with second malignancies that were indolent, in situ or definitively treated may be enrolled even if less than three years have elapsed since treatment. Consult the GSK Medical Monitor if second malignancies meet the requirements specified above.
Second active malignancy requiring systemic therapy
No currently active second malignancy
Active second malignancy that in the opinion of the principal investigator (PI) may interfere with or be adversely affected by this treatment
There is no evidence of the second malignancy at the time of study entry
Second malignancy currently requiring active therapy, except breast or prostate cancer stable on or responding to endocrine therapy.
Active second malignancy
Active second malignancy
Second active neoplasia
A concurrent second active and nonstable malignancy
Patients with a second malignancy requiring active treatment
An active second malignancy or history of another malignancy within the last 5 years, with exceptions.
Active concomitant second malignancy (i.e. has required treatment in the previous 6 months)
Second primary malignancy, only if it would affect the safety of the treatment or the subject’s ability to complete study-related procedures
Second malignancy within the last 3 years
Second malignancy currently requiring active therapy, except breast or prostate cancer stable on or responding to endocrine therapy.
Concurrent second malignancy or history of HER2 negative breast cancer within five years
Active second malignancy i.e. patient known to have potentially fatal cancer present\n for which he/she may be (but not necessarily) currently receiving treatment
Second malignancy requiring active therapy
Evidence of active second malignancy
Subjects with second malignancies in addition to myeloma if the second malignancy has required therapy in the last 3 years or is not in complete remission
Currently active second primary malignancy.
History of a concurrent or second malignancy except for those outlined in protocol
Active second primary malignancy or history of second primary malignancy within the last 3 years, with the exception of basal cell skin cancers or carcinoma in situ that have been adequately treated
Second malignancy within the past 5 years except:
Currently active second malignancy
No active second malignancy (except non-melanomatous skin cancer or incidental prostate cancer found on cystectomy): Active second malignancy is defined as a current need for cancer therapy or a high possibility (> 30%) of recurrence during the study. Previous contralateral breast cancer is allowable unless it meets \active\ criteria as stated above.
Patients with a currently active second malignancy requiring treatment
A concurrent second malignancy even if it does not require active therapy; patients with indolent B-cell malignancies will not be eligible; prior malignancy will be allowed as long as the patient is known to be free of disease for at least 3 years
No currently active second malignancy
A second malignancy requiring active therapy
Patients with active second malignancy are allowed as long as it is determined that the treatment of esophageal cancer is a higher priority through proper subspecialty consultations
Patients with an active, or likely to become active second malignancy.
Active second malignancy; i.e., patient known to have potentially fatal cancer present for which he/she may be (but not necessarily) currently receiving treatment
Second malignancy currently requiring active therapy.
A second invasive malignancy requiring active treatment
Second primary malignancy
No active second malignancy
Patients with an active second malignancy within the last 2 years with the exception of:
Second malignancy within the past 3 years except:
Actively treated for a second malignancy
Untreated second malignancy
Known diagnosis of second malignancy within the past 5 years
Second malignancy except for skin cancer within the last 5 years
No concurrent second malignancy requiring systemic therapy
Has a second concurrent active primary malignancy such as solid tumor or lymphoma under active treatment
Second primary cancer which is active and requiring treatment
Patients with two or more active malignancies (synchronous multiple cancers, or metachronous multiple cancers with a disease-free period of ? 5 years, with the exception of carcinoma in situ, mucosal carcinoma, or other carcinomas that have been curatively treated with local therapy)
Assessment of HER2 status in patients with non-breast/non-gastric cancers may follow local institutional criteria. These criteria should be made available to the Sponsor.
Active second cancers
Subjects must have histologic confirmation of advanced, biopsy-accessible, measurable cancers of the following histologies:
GU cancers with accessible metastases (e.g., bladder, renal)
Other malignancy within 2 years prior to entry into the study, except for those treated with surgical therapy only (e.g., localized low-grade cervical or prostate cancers).
Diagnosis of another malignancy within 2 years before the first dose of cabozantinib, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy
Diagnosis of another malignancy within 2 years before planned first dose of study drug, except for superficial skin cancers, or localized, low grade tumors
Diagnosis of another malignancy within 2 years before the first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy
Patients with salivary gland tumors are excluded (patients with nasopharynx CA or sinonasal cancers can participate)
Patients with primary salivary gland cancers are excluded
Patients with known active cancers who are on therapy for those cancers at time of screening
Prior history of other cancers (except non-melanoma skin cancers or low-grade low-stage urothelial cancers)
Must have select advanced cancers with specific genetic profiles
History of concurrent second cancers requiring active, ongoing systemic treatment.
No other active cancers
Subjects with cytologically or histologically confirmed locally advanced or metastatic HPV associated malignancies including:\r\n* Non-neuroendocrine cervical cancers\r\n* P16+ oropharyngeal cancers\r\n* Anal cancers\r\n* Vulvar, vaginal, penile, squamous cell rectal and neuroendocrine cervical cancers\r\n* Other locally advanced or metastatic solid tumors (e.g. lung, esophagus) that are known HPV+
Active malignancies (that is, requiring treatment change in the last 24 months) other than urothelial cancer (except skin cancers within the last 24 months that is considered completely cured)
Patients with known other active cancers; skin cancers (basal or squamous) are exempted
Patients with primary nasopharynx or salivary gland cancers are excluded
Histological confirmation of advanced biliary tract cancers including cancers originating in gallbladder who have received at least one line of systemic anticancer therapy; \r\n* Note: Patients who have either progressed or intolerant to the prior therapy can be included in this study
Diagnosis of another malignancy within 2 years before the first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy; malignancy felt by investigator to potentially affect subject survival or ability to evaluate disease response
Cancer survivors of the state of Maryland cancers of interest
Histologically confirmed cancers for which no curative therapy exists.
Prior unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ, basal cell carcinoma of the skin, resected T1-2N0M0 differentiated thyroid cancers, invasive cancers with a 3-year disease-free interval, Ta bladder cancers, or low and favorable intermediate risk prostate cancer.
Two or more cancers not resectable through a single lumpectomy incision
Patients with other active cancers receiving anti-cancer agents, with exceptions being hormonal therapy for breast or prostate cancer and skin cancers treated with local therapies only
Current history of neoplasm other than the entry diagnosis. Patients with previous cancers treated and cured with local therapy alone may be considered with approval of the PI
CAPMATINIB EXCLUSION CRITERIA: Diagnosis of concurrent malignancy or previous malignancy within 3 years before study drug administration (exceptions are superficial skin cancers, or any in situ cancers deemed surgically resected, cured and not requiring systemic therapy, and indolent malignancies that currently do not require treatment)
CERITINIB EXCLUSION CRITERIA: Diagnosis of concurrent malignancy or previous malignancy within 3 years before study administration (exceptions are superficial skin cancers, or any in situ cancers deemed surgically resected, cured and not requiring systemic therapy)
Multicentric cancers requiring double lumpectomy
Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years
Active malignancies (that is, requiring treatment change in the last 24 months) other than urothelial cancer (except skin cancers within the last 24 months that are considered completely cured)
History of recent cancers (except for colorectal cancers, non-melanoma skin cancers, basal cell carcinomas, squamous cell carcinomas) in the past 5 years
Presence of other active invasive cancers that do not harbor CCNE1 amplification
Currently being treated for other cancers with medical or radiation therapy
Presence of other active invasive cancers.
All breast cancers with possibility for surgical excision will be included
Advanced metastatic, progressing carcinoid or pancreatic islet cell cancers
No active second cancers
Other invasive cancers that are clinically active
Patients with simultaneous primary cancers or separate bilateral primary tumor sites are excluded with the exception of patients with bilateral tonsil cancers
Patients with T1N0 disease, T4 disease, and proximal esophageal cancers (15-24 cm)
Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low-grade tumors.
Bilateral breast cancers are allowed as long as both cancers are HER2-positive; however, only the primary cancer’s status requires central review
Patients with cancers likely to be Human Papilloma Virus (HPV)-positive such as cervical cancers, oropharyngeal cancers or anal cancers must undergo additional screening to determine eligibility
Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years
Patients with a diagnosis of two co-existing primary cancers are excluded
Human papilloma virus-associated cancers basket\r\n* None
Patients with multiple primary cancers
Two or more breast cancers not resectable through a single lumpectomy incision
History of concurrent second cancers requiring active, ongoing systemic treatment.
Patients must have pathologically or cytologically confirmed adenoid cystic carcinoma; cancers arising from non-salivary gland primary sites are allowed
Has low-grade or non-epithelial cancers, mucinous cancers, and/or borderline low-malignant potential cancers
Patients with other biliary tract cancers (extrahepatic or gallbladder cancers) with IDH1 or IDH2 mutations are allowed
Diagnosis of another malignancy within 2 years of enrollment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy by the principal investigator
No active second cancers
Prior cancers < 3 years, with the exception of in-situ cervical cancer, low grade prostate cancer and basal or squamous cell skin cancers
Patients must have pathologically or cytologically confirmed adenoid cystic carcinoma; cancers arising from non-salivary gland primary sites are allowed
Subjects with simultaneous primary cancers outside of the oropharynx
Patients with BRAF WT cancers
COHORT 1 ONLY: Patients must have pathologically or cytologically confirmed adenoid cystic carcinoma; cancers arising from non-salivary gland primary sites are allowed
Assessment of HER2 status in subjects with non-breast/non-gastric cancers may follow local institutional criteria. These criteria should be made available to the Sponsor.
Up to 12 patients with incurable Squamous cell cancers as follows:
Current history of neoplasm other than the entry diagnosis. Patients with previous cancers treated and cured with local therapy alone may be considered with approval of the Medical Monitor.
Prior diagnoses of any other type of cancer (excluding some skin cancers)
Other cancers diagnosed within the last 5 years (in situ and/or invasive cancers)
Show no current evidence of disease (NED) for solid-tumor cancers.
Previous diagnosis of grade 1 or 2, stage I or II endometrioid endometrial cancers (“type I cancers”) as confirmed during surgical intervention for treatment
Treatment for solid tumor cancers
Diagnosis of stage I-III cancers of the rectosigmoid colon or rectum
History of multiple cancers
Prior cancers allowed if no evidence of disease
Diagnosis of pelvic malignancy (suspected/confirmed ovarian, endometrial/ uterine, cervical cancers, and vulvar cancers) undergoing surgical debulking
No active skin cancers; any skin cancers found on the screening visit after the subject has signed consent will need to be treated before the subject begins on the study drug at the baseline visit; the skin cancers found on the screening visit will not be included in the total number of skin cancers the subject had 2 years prior to signing the consent
History of concurrent second cancers requiring active, ongoing systemic treatment.
HER2/neu-negative breast cancers (IHC 0)
Patients currently on chemotherapy or with other primary cancers requiring systemic or hepatic loco-regional treatment
PATIENT: Patients with other primary cancers requiring systemic treatment
Fludeoxyglucose F 18 (FDG) avid cancers
Patients with other primary cancers requiring systemic treatment.
Patients with other primary cancers requiring systemic treatment
Patient with advanced skin cancers
No other active cancers
Patients with other primary cancers requiring systemic treatment
Diagnosed with advanced NSCLC, breast cancer, GBM or other cancers (such as head and neck, colorectal, pancreatic, renal cancers); patients will undergo anti-angiogenesis treatment or treatment with other drugs that may alter angiogenesis
Patients currently on chemotherapy or with other primary cancers requiring systemic treatment
Participants with second/other active cancers requiring current treatment