Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement
Phase 1 ONLY: histologically or cytologically confirmed advanced/metastatic solid tumors for which carboplatin/etoposide treatment is considered appropriate.
In dose escalation (Phase I), patients must have histologically or cytologically confirmed metastatic disease from any solid tumor that is incurable and fulfills one of the following criteria:\r\n* Has demonstrated progression of disease following at least one line of effective systemic therapy; prior treatment with anti-CTLA-4 antibody (including ipilimumab) is allowable OR\r\n* For which effective therapy does not exist
Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor (including non-Hodgkin Lymphoma) (Stage IV, AJCC v.7) that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement by protocol specified tests.
Participants must have histologically or cytologically confirmed disease from any solid tumor
Histologically or cytologically documented, injectable cancer lesion (limited to solid tumors and mycosis fungoides)
Participants must have histologically or cytologically confirmed disease from any solid tumor
Part A and Part B: Has histologically or cytologically-confirmed metastatic solid tumor.
Histologically or cytologically confirmed advanced solid tumors including:
Has a histologically- or cytologically-confirmed advanced/metastatic solid tumor by pathology report and have received, or been intolerant to, or been ineligible for all treatment known to confer clinical benefit. Participants with solid tumors of any type are eligible for enrollment.
Patients with a histologically or cytologically confirmed solid tumor malignancy
Has a histologically- or cytologically-confirmed advanced/metastatic solid tumor or lymphoma by pathology report and who has received, or been intolerant to, all treatment known to confer clinical benefit. Solid tumors and lymphomas of any type are eligible for enrollment.
Histologically or cytologically-documented, advanced solid tumor of one of the following types:
For enrollment into the NTRK cohort: participants must have a histologically or cytologically confirmed advanced solid tumor and must have received at least one prior line of therapy in the metastatic setting
Diagnosed with histologically confirmed solid tumor located in the peripheral lung
Have histologically or cytologically confirmed diagnosis of advanced solid tumor cancer (excluding lymphomas) for which there is no further standard therapy or when standard therapy is contraindicated. Patients with HGG must have shown unequivocal evidence for recurrence or progression by MRI scan or must have histologically proven tumor recurrence.
Histologically or cytologically confirmed diagnosis of an advanced, malignant, solid tumor(s) with all standard treatment options having been exhausted or declined.
Patients with other immune checkpoint naïve histologically/ cytologically confirmed advanced solid tumor type that has received and progressed on standard-of-care therapy(ies).
Histologically or cytologically confirmed diagnosis of advanced disease of any of the following tumor types:
Histologically/cytologically confirmed advanced/metastatic or unresectable solid tumors, no treatment options
PHASE I: Histologically confirmed solid tumor malignancy
Have a histologically confirmed advanced solid tumor for which curative treatment is not available
Histologically or cytologically confirmed diagnosis of selected advanced or metastatic solid tumors.
Histologically confirmed advanced refractory solid tumor that is measurable or evaluable per RECIST 1.1 criteria.
Histologically or cytologically confirmed solid tumor cancer
Patients must have histologically or cytologically confirmed solid organ malignancy
Patients must have histologically or cytologically confirmed progressive advanced or metastatic solid tumor of one of the following:
Has a histologically or cytologically confirmed diagnosis of a solid tumor malignancy (except for any excluded malignancies listed in the Exclusion Criteria) that is not responsive to standard therapy(ies) or for which there is no approved therapy.
Patients must have histologically (or cytologically)-confirmed diagnosis of solid tumor, refractory after standard therapy for the disease or for which conventional systemic therapy is not reliably effective or no effective therapy is available.
Solid tumor specific:\r\n* Patients must have a histologically/cytologically confirmed primary solid tumor\r\n* Radiographic or clinical evidence of advanced/metastatic disease that is resistant to standard therapy or for which no standard therapy is available; lesions may be measurable or non-measurable
Have a histologically confirmed advanced solid tumor for which curative treatment is not available
Histologically confirmed malignant extra-cranial solid tumor or desmoid fibromatosis.
Patients with a histologically-confirmed, advanced solid malignancy for which pembrolizumab is approved (Parts C and D)
Histologically or cytologically confirmed advanced solid tumor malignancy, refractory or relapsed from prior therapy, or for whom no alternative therapy is available
Histologically or cytologically confirmed diagnosis of solid malignant tumor.
Patients with histologically or cytologically confirmed diagnosis of refractory metastatic solid tumor for whom no other standard treatment options are available
Arm 1: histologically or cytologically confirmed solid tumors that are advanced that gemcitabine-based treatment is considered a clinically appropriate option
Arm 3: histologically or cytologically confirmed solid tumors that are advanced that gemcitabine plus cisplatin treatment is considered a clinically appropriate option
Phase Ib: Patient must have histologically or cytologically documented solid tumor malignancies
Part 1a: Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (including subject refusal or intolerance).
(Combination Therapy - Part E and Part F) -- Histologically or cytologically confirmed advanced or metastatic solid malignancy for which pembrolizumab treatment is approved. In Part F, other advanced solid tumor indications may be eligible as identified by the Sponsor.
Histologically confirmed malignant solid tumor and not a candidate for known regimens or protocol treatments of higher efficacy or priority
Histologically or cytologically confirmed diagnosis of advanced cancer in patients with solid tumors that are refractory to standard treatment, or for whom no effective therapy exists.
Histologically or cytologically confirmed solid tumors or hepatocellular carcinoma with known disease progression.
Histologically confirmed advanced solid tumors with measurable lesions per RECIST v1.1 that are considered nonamenable to surgery or other curative treatments or procedures.
Patients with histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor disease for which standard therapy is not effective, available, acceptable, or is intolerable.
ARM B: Histologically or cytologically confirmed solid tumor with subcutaneous/cutaneous lesions that is refractory (RECIST or with unequivocal clinical progression of disease) to or intolerant to standard therapy
Patients must have histologically and/or cytologically confirmed solid tumors or B cell lymphoma that are metastatic or unresectable and for which standard treatment options do not exist; patients with hepatocellular carcinoma are eligible without pathological diagnosis if diagnosed on the basis of blood work and imaging
Histologically confirmed solid tumor (leukemia and lymphoma are excluded)
Histologically- or cytologically- confirmed solid tumor (except melanoma) that is\n metastatic or unresectable
Histologically or cytologically confirmed diagnosis of malignancy with demonstrated progression of a solid tumor (non-lymphoma) with no alternative standard-of-care therapeutic option (certain exceptions may apply).
For the phase I portion, patients must have histologically and/or cytologically confirmed malignant solid tumor that is refractory to standard therapies
Subjects with histologically or cytologically confirmed advanced solid tumors or lymphoma that is metastatic or unresectable, and for whom standard life-prolonging measures are not available. Specific tumor types that will be selected for study in Phase 2 are detailed in the protocol.
Part 1: Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (disease progression; subject refusal or intolerance is also allowable).
Subject must have histologically or cytologically confirmed solid tumor;
Subjects must have histologically or cytologically confirmed advanced solid tumor for recurrent or metastatic disease.
Histologically or cytologically documented, incurable or metastatic solid tumor or hematologic malignancy that is advanced (non-resectable) or recurrent and progressing since the last anti-tumor therapy and for which no recognized standard curative therapy exists
Men and women, 18 years or older, with histologically or cytologically-confirmed, advanced solid tumors, Non-Hodgkin Lymphona (NHL), Multiple Myloma (MM), or advanced unresectable solid tumors limited to the tumor types below.
For Phase 1, subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (disease progression; subject intolerance is also allowable).
Part A only: Histologically or cytologically confirmed metastatic and/or advanced solid tumors with documented progressive disease for whom no further standard therapy is indicated.
Subjects must have a histologically or cytologically confirmed advanced or metastatic tumor for which no effective standard therapy is available.
Diagnosis of histologically or cytologically confirmed, advanced solid tumor malignancy that is refractory to or not a candidate for standard therapy
Histologically or cytologically confirmed diagnosis of selected advanced or metastatic solid tumors.
Patients with histologically or cytologically confirmed solid malignancy are eligible for treatment as long as insurance approval for docetaxel is obtained
A histologically confirmed solid tumor of the gastrointestinal tract including
In the dose-expansion phase: histologically- or cytologically- confirmed advanced solid tumor where if an approved first-line therapy is available, subjects must have failed, be intolerant to, be ineligible for, or have refused
Phase Ia: Patients must have histologically or cytologically documented metastatic solid tumor malignancies
Presumptive or histologically confirmed advanced or metastatic non-curable solid tumor (if limited to a single lesion, and may not be a candidate for curative surgery or radiation therapy).
Patients must have a histologically or cytologically confirmed metastatic solid tumor malignancy for the phase I component; the phase II component will require patients to have histologically or cytologically confirmed non-small cell lung carcinoma regardless of histology
Subjects with advanced, histologically or cytologically confirmed solid tumors described to express fibroblast growth factor receptor 2 (FGFR2) that are refractory to any standard therapy
Subjects with a histologically or cytologically confirmed diagnosis of solid tumors, advanced or metastatic, refractory to or relapsed from standard therapies or for which there is no known effective treatment
For Part 1a: Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (including subject refusal or intolerance).
Histologically or cytologically confirmed diagnosis of solid malignancy, for which no standard curative or life prolonging therapy is available.
Treatment Group A (TGA): Part 1 and Part 2: Any advanced solid tumor or lymphoma; Part 3: Histologically confirmed disease in specific solid tumors and lymphomas
Histologically or cytologically confirmed solid tumor.
Histologically or cytologically confirmed advanced solid tumor with no available standard treatment options in the opinion of the investigator.
Part A Subjects with histologically or cytologically confirmed malignant advanced solid tumors, who have progressed on at least 1 prior chemotherapy, and for whom either
Subject had histologically or cytologically confirmed diagnosis of advanced solid tumor (measurable or nonmeasurable disease) for which no standard therapy is available.
Must have a histologically or cytologically confirmed metastatic or locally advanced and incurable solid tumor that is deemed appropriate for treatment with 1 of the 2 chemotherapy regimens in Part B of this study, or have progressed despite standard therapy, or for whom conventional therapy is not considered effective. The tumor must be radiographically or clinically evaluable or measurable.
Histologically or cytologically confirmed diagnosis of solid tumor malignancy that is not responsive to standard therapies or for which there is no approved or curative therapy.
Have a histologically or cytologically confirmed diagnosis of advanced solid tumor or lymphoma, or primitive hepatocarcinoma with radiological diagnosis
Histologically or cytologically confirmed diagnosis of a solid tumor.
Dose escalation phase: Subjects with histologically or cytologically confirmed advanced malignancies (solid tumors and malignant lymphomas) who were refractory to or had exhausted all available therapies. Subjects had to have evaluable or measurable disease (as per RECIST 1.1 or Cheson 2007 criteria).
Patients must have a histologically or cytologically confirmed metastatic or locally advanced and incurable solid tumor that is felt to be appropriate for treatment with 1 of the 3 chemotherapy regimens in this study, or have progressed despite standard therapy, or for whom conventional therapy is not considered effective. The tumor must be radiographically or clinically evaluable and/or measurable
Histologically or cytologically confirmed diagnosis of a solid tumor for which no further effective standard treatment is available. Patients with lymphomas may be enrolled.
Histologically or cytologically confirmed diagnosis of solid tumor in advanced stage which taxane-based therapy is a rational treatment option.
Patients aged ?18 years with a histologically or cytologically confirmed diagnosis of a solid tumor or lymphoma for which no further effective standard treatment is available
Patients with a histologically and/or cytologically confirmed solid tumor who are resistant / refractory to approved therapies or for whom no curative therapies are available
Histologically or cytologically confirmed diagnosis of solid malignancy
(Part 1 only) Have a histologically/cytologically confirmed diagnosis of advanced solid tumor, including sarcoma that is refractory to standard therapy. (Part 2 only) Have a histologically confirmed diagnosis of advanced, unresectable, or metastatic soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy.
Histologically or cytologically confirmed advanced solid tumor with no available standard treatment options in the opinion of the Investigator
Histologically or cytologically confirmed advanced solid tumor with no available standard approved treatment options in the opinion of the Investigator
Histologically or cytologically confirmed cancer (hematologic or solid) who are not currently on hospice care
Patients with a histologically or cytologically confirmed solid tumor or aggressive NHL who are refractory to or have exhausted all available therapies
For Part 1: Histologically- or cytologically-confirmed diagnosis of unresectable GIST or another advanced solid tumor. Patients with unresectable GIST must have disease that has progressed following imatinib and at least 1 of the following: sunitinib, regorafenib, sorafenib, dasatinib, pazopanib or an experimental kinase-inhibitor agent, or disease with a D842 mutation in the PDGFR? gene. Patients with an advanced solid tumor other than GIST must have relapsed or refractory disease without an available effective therapy. OR For Part 2:
Participants must have histologically or cytologically confirmed diagnosis of solid tumor malignancy, lymphoma, or multiple myeloma
Participants must have histologically confirmed diagnosis of a solid tumor for which no curative therapy exists
For Parts A and B: Has histologically or cytologically confirmed metastatic solid tumor
Somatostatin receptor 2 positive tumor as assessed at pre-screening or within 180 d of first drug administration using indium SPECT or gallium PET Patients in Phase 1 must have a histologically or cytologically-confirmed solid tumor in 1 of the following categories:
For patients enrolling once escalation is complete, disease must be measurable per RECIST 1.1 criteria with last imaging performed within 28 days prior to first drug dose In addition to the criterion listed above, Patients in Phase 2a must have a histologically- or cytologically-confirmed, advanced or metastatic solid tumor, in 1 of the following categories: disease history specificied in one of the criteria listed below:
Participants must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor(s) appropriate for treatment with one of the 2 combination therapies in Part B of this study, have progressed despite standard therapy, or for whom conventional therapy is not considered effective.
Adult participants who have a histologically or cytologically confirmed metastatic or locally advanced solid tumor that is appropriate for treatment with either docetaxel or carboplatin + paclitaxel in Part B of this study, or have progressed despite standard therapy, or for whom conventional therapy is not considered effective. The tumor must be radiographically or clinically evaluable and/or measurable.
Patients with a histologically confirmed solid tumor: