Clinical Trials

Primary objective:

Maximum tolerated dose of nivolumab [Time Frame: 56 days]
Will be defined as the starting dose level at which 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least >= 2 participants encountering DLT. Toxicity data will be presented by type and severity for each dose group and overall; the incidence of toxicity related dose reductions and treatment discontinuations will be summarized.

Secondary objectives:

1. Objective response rate [Time Frame: Up to 3 years]
   The proportion of patients achieving objective responses (by Response Evaluation Criteria In Solid Tumors 1.1 or Kaposi's sarcoma response criteria, which includes RECIST for visceral disease, or by Response Evaluation Criteria in Lymphoma for classical Hodgkin lymphoma [cHL]) and their corresponding 95% confidence intervals (calculated using exact binomial

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Primary objective:

Maximum tolerated dose of nivolumab [Time Frame: 56 days]
Will be defined as the starting dose level at which 1/6 subjects experience dose limiting toxicity (DLT) with the next higher dose having at least >= 2 participants encountering DLT. Toxicity data will be presented by type and severity for each dose group and overall; the incidence of toxicity related dose reductions and treatment discontinuations will be summarized.

Secondary objectives:

1. Objective response rate [Time Frame: Up to 3 years]
   The proportion of patients achieving objective responses (by Response Evaluation Criteria In Solid Tumors 1.1 or Kaposi's sarcoma response criteria, which includes RECIST for visceral disease, or by Response Evaluation Criteria in Lymphoma for classical Hodgkin lymphoma [cHL]) and their corresponding 95% confidence intervals (calculated using exact binomial

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Primary objective:
To compare radiographic progression-free survival (rPFS) and overall survival (OS) with enzalutamide and rucaparib versus enzalutamide alone for patients with metastatic castration resistant prostate cancer commencing first-line therapy.

Secondary objectives:
In patients commencing enzalutamide as the first-line therapy for metastatic castration resistant prostate cancer, to evaluate the effects of concurrent administration of rucaparib on:

• rPFS and OS within HRR mutant and wild-type patients
• Time to unequivocal clinical progression
• Best radiographic response using prostate cancer working group 3 (PCWG3) criteria
• Duration of overall response
• PSA response rate
• Best response by serum PSA by months 7 and 13 using categorical and continuous measures.
• Time to first symptomatic skeletal event (SSE)
• Safety and tolerability as measured by NCI
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Primary objective:
To compare overall survival in metastatic prostate cancer patients who are randomized to standard systemic therapy (SST) plus definitive treatment of the primary tumor versus standard systemic therapy alone.

Secondary objectives:

1. To compare overall survival in metastatic prostate cancer patients who received SST plus surgical excision of the primary tumor versus SST alone in the subset who specify the surgical intent stratification factor.
2. To compare the rate of symptomatic local progression between the treatment arms.
3. To compare progression-free survival (PFS) between the two treatment arms.
4. To compare rates of progression-free survival between arms for the subsets of patients with and without metastasis directed therapy (MDT) to oligometastatic sites.

Inclusion Criteria:

1. All patients must have a histologically or cytologically proven
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Primary objective:
To compare the overall survival (OS) in patients with metastatic RCC treated with ipilimumabnivolumab followed by either nivolumab versus cabozantinib-nivolumab.

Secondary objectives:

• To determine PFS of patients treated with nivolumab versus nivolumab-cabozantinib
• To evaluate the 12-month complete response rate in patients treated with ipilimumabnivolumab followed by cabozantinib-nivolumab versus ipilimumab-nivolumab followed by nivolumab (patients who have CR and relapse before 12 months will not be counted as a CR at 12-months)
• To evaluate the rates of discontinuing therapy at 1 year
• To compare objective response rates (ORR, assessed by RECIST 1.1 and irRECIST criteria) for patients treated with ipilimumab-nivolumab followed by cabozantinib-nivolumab versus ipilimumab-nivolumab followed by nivolumab.
• To document the adverse event profile of ipilimumab-nivolumab
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