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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00145104 | Other Identifier | University of Michigan |
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| Name | Class |
|---|---|
| Memorial Sloan Kettering Cancer Center | OTHER |
| University of California, San Francisco | OTHER |
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This study will attempt to determine the efficacy of checkpoint inhibitor immunotherapy with nivolumab and ipilimumab combination therapy followed by nivolumab monotherapy in patients with metastatic prostate cancer and other tumor solid tumor histologies harboring loss of CDK12 function as well as monotherapy nivolumab treatment in patient with metastatic prostate cancer harboring loss of CDK12 function.
This study investigates the efficacy of checkpoint inhibitor immunotherapy in patients with metastatic cancer with CDK12 mutations. The study includes three cohorts: Cohort A consists of metastatic prostate cancer patients being treated with combination nivolumab and ipilimumab treatment followed by monotherapy nivolumab treatment. Cohort B consists of other solid tumor patients being treated with combination nivolumab and ipilimumab treatment followed by monotherapy nivolumab treatment. As of an amendment approved 03FEB2021 a third cohort was added, Cohort C, which consists of metastatic prostate cancer patients being treated with monotherapy nivolumab treatment.
As of an amendment approved 21JUN2020 the maximum duration of treatment, as well as the anticipated timing for some of the studies outcome measures, were updated from 52 weeks to 104 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic CRPC | Experimental | Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort A. |
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| Solid Tumors (non-prostate) | Experimental | Patients with all other metastatic subtypes will be enrolled in cohort B |
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| Metastatic CRPC with Monotherapy | Experimental | Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort C once enrollment to cohort A has been completed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Drug | Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Patients With CDK12 Loss of Function Metastatic CRPC That Respond to Treatment. | The primary objective is overall response rate (ORR) of patients with metastatic CRPC. Response will be defined as a 50% decline in PSA (prostate specific antigen) from baseline as determined by PCWG3 criteria. | Up to 24 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Patients That Respond to Treatment in Cohort B. | Overall response will be defined as patients that achieve either a partial response or complete response using RECIST 1.1 criteria. Complete response (CR) is defined as disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ajjai Alva, MD | Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego, Moores Cancer Center | San Diego | California | 92093 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Metastatic CRPC | Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort A. Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. Ipilimumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2021 |
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| Ipilimumab | Drug | Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. |
|
| Up to 104 weeks after start of therapy |
| Radiographic Progression Free Survival Time (rPFS) | Radiographic progression-free survival (rPFS) is defined as the duration of time from start of treatment to time of radiographic progression. Progression is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions. | Up to 104 weeks after start of therapy |
| Progression Free Survival Time (PFS) | Progression is defined as the duration of time from start of treatment to time of progression. Progression is defined as: Either, Radiographic progression: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions OR, PSA Progression: For rising PSA after an initial decline from baseline, the PSA is recorded from the start of therapy to first PSA increase that is ≥ 25% and ≥ 2ng/mL above the nadir, which is confirmed by a second value 4 or more weeks later, confirming a rising trend. If there is no initial decline from baseline, PSA progression is defined as ≥ 25% increase and ≥ 2 ng/mL increase from baseline beyond 12 weeks. | Up to 24 months post treatment |
| Duration of Therapy (DOT) | Defined by the time interval from the start of treatment to the day of permanent discontinuation of treatment (including death). | Up to 104 weeks after start of therapy |
| Progression Rate at 6 Months | Progression is defined as: Either, Radiographic progression: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions OR, PSA Progression: For rising PSA after an initial decline from baseline, the PSA is recorded from the start of therapy to first PSA increase that is ≥ 25% and ≥ 2ng/mL above the nadir, which is confirmed by a second value 4 or more weeks later, confirming a rising trend. If there is no initial decline from baseline, PSA progression is defined as ≥ 25% increase and ≥ 2 ng/mL increase from baseline beyond 12 weeks. | 6 months |
| Overall Survival Time | Defined as the time from the start of treatment until death from any cause. Patients alive or lost to follow-up at the time of analysis will be censored at their last date of follow-up. | Up to 24 months post treatment |
| PSA Progression Free Survival Time | PSA Progression: For rising PSA after an initial decline from baseline, the PSA is recorded from the start of therapy to first PSA increase that is ≥ 25% and ≥ 2ng/mL above the nadir, which is confirmed by a second value 4 or more weeks later, confirming a rising trend. If there is no initial decline from baseline, PSA progression is defined as ≥ 25% increase and ≥ 2 ng/mL increase from baseline beyond 12 weeks. | Up to 24 months post treatment |
| Time to PSA Progression | PSA Progression: For rising PSA after an initial decline from baseline, the PSA is recorded from the start of therapy to first PSA increase that is ≥ 25% and ≥ 2ng/mL above the nadir, which is confirmed by a second value 4 or more weeks later, confirming a rising trend. If there is no initial decline from baseline, PSA progression is defined as ≥ 25% increase and ≥ 2 ng/mL increase from baseline beyond 12 weeks. | Up to 24 months post treatment |
| University of California San Francisco/Helen Diller Family Comprehensive Cancer Center |
| San Francisco |
| California |
| 94158 |
| United States |
| H. Lee. Moffitt Cancer Center & Research Institute, Inc. | Tampa | Florida | 33612 | United States |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | United States |
| University of Michigan Rogel Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Siteman Cancer Center at Washington University | St Louis | Missouri | 63110 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| FG001 | Solid Tumors (Non-prostate) | Patients with all other metastatic subtypes will be enrolled in cohort B Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. Ipilimumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. |
| FG002 | Metastatic CRPC With Monotherapy | Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort C once enrollment to cohort A has been completed. Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Metastatic CRPC | Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort A. Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. Ipilimumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. |
| BG001 | Solid Tumors (Non-prostate) | Patients with all other metastatic subtypes will be enrolled in cohort B Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. Ipilimumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. |
| BG002 | Metastatic CRPC With Monotherapy | Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort C once enrollment to cohort A has been completed. Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
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| Primary | The Proportion of Patients With CDK12 Loss of Function Metastatic CRPC That Respond to Treatment. | The primary objective is overall response rate (ORR) of patients with metastatic CRPC. Response will be defined as a 50% decline in PSA (prostate specific antigen) from baseline as determined by PCWG3 criteria. | only subjects who received at least 1 cycle(s) of therapy, and who have 2 PSA measurements after protocol therapy initiation were considered evaluable for PSA response. | Posted | Number | 95% Confidence Interval | participants | Up to 24 months post treatment |
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| Secondary | The Proportion of Patients That Respond to Treatment in Cohort B. | Overall response will be defined as patients that achieve either a partial response or complete response using RECIST 1.1 criteria. Complete response (CR) is defined as disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions. | Only Cohort B analyzed and only 3 patients were evaluable per RECIST | Posted | Count of Participants | Participants | Up to 104 weeks after start of therapy |
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| Secondary | Radiographic Progression Free Survival Time (rPFS) | Radiographic progression-free survival (rPFS) is defined as the duration of time from start of treatment to time of radiographic progression. Progression is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions. | numbers updated to include only evaluable patients | Posted | Median | 95% Confidence Interval | days | Up to 104 weeks after start of therapy |
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| Secondary | Progression Free Survival Time (PFS) | Progression is defined as the duration of time from start of treatment to time of progression. Progression is defined as: Either, Radiographic progression: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions OR, PSA Progression: For rising PSA after an initial decline from baseline, the PSA is recorded from the start of therapy to first PSA increase that is ≥ 25% and ≥ 2ng/mL above the nadir, which is confirmed by a second value 4 or more weeks later, confirming a rising trend. If there is no initial decline from baseline, PSA progression is defined as ≥ 25% increase and ≥ 2 ng/mL increase from baseline beyond 12 weeks. | Posted | Median | 95% Confidence Interval | days | Up to 24 months post treatment |
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| Secondary | Duration of Therapy (DOT) | Defined by the time interval from the start of treatment to the day of permanent discontinuation of treatment (including death). | Posted | Median | Inter-Quartile Range | weeks | Up to 104 weeks after start of therapy |
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| Secondary | Progression Rate at 6 Months | Progression is defined as: Either, Radiographic progression: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions OR, PSA Progression: For rising PSA after an initial decline from baseline, the PSA is recorded from the start of therapy to first PSA increase that is ≥ 25% and ≥ 2ng/mL above the nadir, which is confirmed by a second value 4 or more weeks later, confirming a rising trend. If there is no initial decline from baseline, PSA progression is defined as ≥ 25% increase and ≥ 2 ng/mL increase from baseline beyond 12 weeks. | Posted | Number | 95% Confidence Interval | percentage of Participants | 6 months |
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| Secondary | Overall Survival Time | Defined as the time from the start of treatment until death from any cause. Patients alive or lost to follow-up at the time of analysis will be censored at their last date of follow-up. | Posted | Median | 95% Confidence Interval | days | Up to 24 months post treatment |
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| Secondary | PSA Progression Free Survival Time | PSA Progression: For rising PSA after an initial decline from baseline, the PSA is recorded from the start of therapy to first PSA increase that is ≥ 25% and ≥ 2ng/mL above the nadir, which is confirmed by a second value 4 or more weeks later, confirming a rising trend. If there is no initial decline from baseline, PSA progression is defined as ≥ 25% increase and ≥ 2 ng/mL increase from baseline beyond 12 weeks. | Only evaluable prostate cancer patients were analyzed as PSA is only collected for prostate cancer participants. | Posted | Median | 95% Confidence Interval | days | Up to 24 months post treatment |
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| Secondary | Time to PSA Progression | PSA Progression: For rising PSA after an initial decline from baseline, the PSA is recorded from the start of therapy to first PSA increase that is ≥ 25% and ≥ 2ng/mL above the nadir, which is confirmed by a second value 4 or more weeks later, confirming a rising trend. If there is no initial decline from baseline, PSA progression is defined as ≥ 25% increase and ≥ 2 ng/mL increase from baseline beyond 12 weeks. | Only evaluable prostate cancer patients were analyzed as PSA is only collected for prostate cancer participants. | Posted | Median | 95% Confidence Interval | days | Up to 24 months post treatment |
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All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 100 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 100 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 4.5 year period. An average of 6.5 months per participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metastatic CRPC | Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort A. Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. Ipilimumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. | 21 | 33 | 16 | 33 | 32 | 33 |
| EG001 | Solid Tumors (Non-prostate) | Patients with all other metastatic subtypes will be enrolled in cohort B Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. Ipilimumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. | 3 | 8 | 6 | 8 | 7 | 8 |
| EG002 | Metastatic CRPC With Monotherapy | Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort C once enrollment to cohort A has been completed. Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. | 6 | 15 | 4 | 15 | 14 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
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| Abdominal pain | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Anorexia | Psychiatric disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE version 4.03 | Non-systematic Assessment | Bacteremia |
|
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | CTCAE version 4.03 | Non-systematic Assessment | acute myeloid leukemia |
|
| Dehydration | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Generalized muscle weakness | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Headache | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Hepatobiliary disorders - Other, specify | Hepatobiliary disorders | CTCAE version 4.03 | Non-systematic Assessment | immune mediated hepatitis |
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| Hoarseness | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Kidney infection | Renal and urinary disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE version 4.03 | Non-systematic Assessment | disease progression |
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| Nervous system disorders - Other, specify | Nervous system disorders | CTCAE version 4.03 | Non-systematic Assessment | Cord compression |
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| Pain | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
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| Pancreatitis | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
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| Paroxysmal atrial tachycardia | Vascular disorders | CTCAE version 4.03 | Non-systematic Assessment |
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| Pleural effusion | Infections and infestations | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Pneumonitis | Infections and infestations | CTCAE version 4.03 | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Seizure | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | CTCAE version 4.03 | Non-systematic Assessment |
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| Tumor pain | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
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| Alkaline phosphatase increased | Investigations | CTCAE version 4.03 | Non-systematic Assessment |
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| Anemia | Investigations | CTCAE version 4.03 | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE version 4.03 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | CTCAE version 4.03 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Non-systematic Assessment |
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| Chills | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
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| Colitis | Gastrointestinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
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| Creatinine increased | Investigations | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Eyelid function disorder | Eye disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Fecal incontinence | Gastrointestinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Hyperkalemia | Investigations | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Infusion related reaction | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Blood and lymphatic system disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Pain in extremity | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Pulmonary hypertension | Vascular disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Serum amylase increased | Investigations | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Sinus disorder | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE version 4.03 | Non-systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Ascites | Musculoskeletal and connective tissue disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Bronchial infection | Infections and infestations | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Localized edema | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Skin infection | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Sore throat | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Hypoglycemia | Infections and infestations | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Hyponatremia | Investigations | CTCAE version 4.03 | Non-systematic Assessment |
| |
| INR increased | Investigations | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Oral dysesthesia | Gastrointestinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Renal calculi | Renal and urinary disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Testicular pain | Respiratory, thoracic and mediastinal disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | CTCAE version 4.03 | Non-systematic Assessment |
| |
| Weight gain | Investigations | CTCAE version 4.03 | Non-systematic Assessment |
|
Other sites/PI's are not to publish
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| University of Michigan Cancer Center Admin | University of Michigan Rogel Cancer Center | 7349369499 | ClinicalTrialsgov_CCAdmin@umich.edu |
| Dec 20, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 7, 2022 | Dec 20, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Solid Tumors (Non-prostate) | Patients with all other metastatic subtypes will be enrolled in cohort B Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. Ipilimumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. |
| OG002 | Metastatic CRPC With Monotherapy | Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort C once enrollment to cohort A has been completed. Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. |
|
|
| OG001 |
| Solid Tumors (Non-prostate) |
Patients with all other metastatic subtypes will be enrolled in cohort B Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. Ipilimumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. |
| OG002 | Metastatic CRPC With Monotherapy | Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort C once enrollment to cohort A has been completed. Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. |
|
|
| OG001 | Solid Tumors (Non-prostate) | Patients with all other metastatic subtypes will be enrolled in cohort B Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. Ipilimumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. |
| OG002 | Metastatic CRPC With Monotherapy | Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort C once enrollment to cohort A has been completed. Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. |
|
|
| OG002 | Metastatic CRPC With Monotherapy | Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort C once enrollment to cohort A has been completed. Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. |
|
|
| OG001 | Solid Tumors (Non-prostate) | Patients with all other metastatic subtypes will be enrolled in cohort B Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. Ipilimumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. |
| OG002 | Metastatic CRPC With Monotherapy | Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort C once enrollment to cohort A has been completed. Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. |
|
|
| OG002 | Metastatic CRPC With Monotherapy | Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort C once enrollment to cohort A has been completed. Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. |
|
|
| OG001 | Solid Tumors (Non-prostate) | Patients with all other metastatic subtypes will be enrolled in cohort B Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. Ipilimumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. |
| OG002 | Metastatic CRPC With Monotherapy | Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort C once enrollment to cohort A has been completed. Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. |
|
|
| OG001 | Solid Tumors (Non-prostate) | Patients with all other metastatic subtypes will be enrolled in cohort B Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. Ipilimumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. |
| OG002 | Metastatic CRPC With Monotherapy | Patients with metastatic castration resistant prostate cancer (mCRPC) will be enrolled in cohort C once enrollment to cohort A has been completed. Nivolumab: Patients in arms Metastatic CRPC and Experimental: Solid Tumors (non-prostate) will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 104 weeks of total therapy. Patients in arm Metastatic CRPC will receive therapy with monotherapy nivolumab therapy at flat dose 480 mg IV every 4 weeks for up to 104 weeks of total therapy. |
|
|