Objective:

Primary Objective(s):

• To compare progression-free survival in participants with metastatic papillary renal cell carcinoma (mPRCC) randomized to cabozantinib with atezolizumab versus cabozantinib alone.
   

Secondary Objective(s):

• To compare overall survival in participants with mPRCC randomized to cabozantinib with atezolizumab versus cabozantinib alone.
• To compare RECIST objective response rate (confirmed and unconfirmed, complete and partial response) in participants with mPRCC randomized to cabozantinib with atezolizumab versus cabozantinib alone.
• To evaluate the quantitative & qualitive adverse events observed in each treatment arm.

Objective:

Primary Objectives:

• To determine the event free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical BCG vs GEMDOCE.
   

Secondary Objectives:

• To compare changes in cancer-specific and bladder cancer-specific QOL from baseline to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE.
• To determine the cystectomy free survival (CFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.
• To determine the progression free survival (PFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.
• To determine the safety and toxicity of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.

Objective:

Primary Objectives:

• To assess the safety and tolerability of AB248 alone or in combination with pembrolizumab

Secondary Objectives:

• To assess the preliminary antitumor effect of AB248 alone or in combination with pembrolizumab
• To assess the PK of AB248 alone or in combination with pembrolizumab
• To assess the relationship between AB248 PK and biomarkers of pharmacodynamic response to AB248 alone or in combination with pembrolizumab
• To assess the immunogenicity of AB248 when administered alone or in combination with pembrolizumab

Objective:

Primary Objectives:

De-Intensification Study:

• To determine whether men with NCCN high risk prostate cancer who are in the lower 2/3 of Decipher genomic risk (< 0.85) can be treated with 12 months ADT plus RT instead of 24 months ADT+RT and experience non-inferior metastasis-free survival.

Intensification Study:

• To determine whether men with NCCN high risk prostate cancer who are in the upper 1/3 of Decipher genomic risk (>0.85) or have node-positive disease by conventional imaging (MRI or CT scan) will have a superior metastasis-free survival (MFS) through treatment intensification with apalutamide added to the standard of RT plus 24 month ADT.

Secondary Objectives for both De-Intensification and Intensification Studies:

• To compare overall survival (OS) between the standard of care (RT plus 24 months of ADT) and either the de-intensification (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide).
• To compare time to PSA failure or start of salvage treatment between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide).
• To compare PSA failure-free survival with non-castrate testosterone and no additional therapies between the standard of care (RT plus 24 months of ADT) and either the deintensification arm  RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide).
• To compare MFS judged based on either standard or molecular imaging between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plusapalutamide).
• To compare prostate cancer-specific mortality between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide).
• To compare testosterone levels at the time of PSA failure and metastases between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide).
• To compare time to testosterone recovery (defined as a T>200) between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide).
• To compare adverse events, both clinician-reported using CTCAE v5.0 and patientreported using PRO-CTCAE items, between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide).

Objective:

Primary Objective:

De-Intensification Study:

• To determine whether men with National Comprehensive Cancer Network (NCCN) unfavorable intermediate risk (UIR) prostate cancer and lower Decipher genomic risk (Decipher score < 0.40) treated with RT alone instead of 6 months ADT + RT experience non-inferior rate of distant metastasis.

Intensification Study:

• To determine whether men with NCCN UIR prostate cancer who are in the higher genomic risk (Decipher score ≥0.40) will have a superior metastasis-free survival through treatment intensification with darolutamide added to the standard of RT plus 6 months ADT.

Secondary Objectives:

• To compare overall survival (OS) between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
• To compare time to PSA failure between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
• To compare metastasis free survival (MFS) based on conventional imaging between the standard of care (RT plus 6 months of ADT) and de-intensification intervention (RT alone).
• To compare MFS based on either conventional and/or molecular imaging between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
• To compare cumulative incidence of locoregional failure based upon conventional imaging and/ or biopsy between standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months ADT plus darolutamide) interventions.
• To compare cumulative incidence of distant metastasis based upon conventional imaging between standard of care (RT plus 6 months of ADT) and intensification intervention (RT plus 6 months ADT plus darolutamide).
• To compare cumulative incidence of distant metastasis based upon either conventional and/or molecular imaging between standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
• To compare prostate cancer-specific mortality between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
• To compare sexual and hormonal related quality of life, as measured by the Expanded Prostate Cancer Index Composite-26 (EPIC), between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
• To compare fatigue, as measured by the PROMIS-Fatigue instrument, between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.
• To compare cognition, as measured by the Functional Assessment of Chronic Illness Therapy-Cognitive (FACT-Cog) perceived cognitive abilities subscale, between the standard of care (RT plus 6 months of ADT) and either the de-intensification (RT alone) or intensification (RT plus 6 months of ADT plus darolutamide) interventions.

Objective:

Objective:

Primary Objectives:

Phase 1a: Dose Escalation

• To assess safety and tolerability at increasing dose levels of ALLO-316 in successive cohorts of subjects with advanced or metastatic ccRCC to estimate the maximum tolerated dose (MTD) of ALLO-316 administered following lymphodepletion and to select at least 1 Phase 1b expansion cohort dose regimen of ALLO-316.
• To assess safety and tolerability of Flu and/or Cy in combination with or without ALLO-647 prior to ALLO-316
• To assess safety and tolerability of other lymphodepletion regimens administered prior to ALLO-316, which may include cyclophosphamide/ALLO-647 (CA), fludarabine/ALLO-647 (FA), or ALLO-647 alone (A).

Phase 1b: Dose Expansion

• To evaluate the safety, tolerability, and preliminary efficacy of ALLO-316 at the Phase 1b expansion cohort dose regimen, determine the recommended phase 2 regimen (RP2R), and evaluate the necessity of assessing CD70 expression in subject selection.

Secondary Objectives:

• To evaluate the overall safety profile of ALLO-316 following lymphodepletion including or withholding ALLO-647).
• To evaluate antitumor activity of ALLO-316.
• To characterize cellular kinetics of ALLO-316.
• To characterize the pharmacokinetics of ALLO-647.
• To evaluate immunogenicity against ALLO-316 and ALLO-647.
• To evaluate correlation of clinical outcomes with baseline tumor CD70 expression.

Objective:

Primary Objectives:

• Evaluate the safety and tolerability of intravenous ICVB-1042
• Determine the maximum tolerated dose (MTD) (Part A)
• Define the recommended Phase 2 dose (RP2D) for ICVB-1042

Secondary Objectives:

• Evaluate plasma PK of ICVB-1042 following intravenous injection(s)
• Characterize immunogenicity of ICVB-1042 following intravenous injection(s)

Objective:

Primary Objectives:

• Evaluate the safety, tolerability and the maximum tolerated dose (MTD) / recommended dose for expansion (RDE) of ABSK121-NX in patients with advanced solid tumors
• Determine the Recommended Phase 2 dose(s) (RP2D) of ABSK121-NX

Secondary Objectives:

• Characterize the pharmacokinetic (PK) profile of ABSK121-NX
• Evaluate the preliminary anti-tumor activity of ABSK121-NX

Objective:

Dose Escalation

Primary Objective

• To assess the safety and tolerability of AB598 in patients with advanced malignancies

Secondary Objectives

• To describe the PK profile of AB598 in patients with advanced malignancies
• To assess the immunogenicity to AB598 in patients with advanced malignancies
• To assess the clinical activity of AB598 in participants with advanced malignancies

Dose Expansion

Primary Objective

• To characterize the safety and tolerability of AB598 in combination with zimberelimab and standard chemotherapies in participants with advanced malignancies

Secondary Objectives

• To characterize the PK profile of AB598 in combination with zimberelimab and standard chemotherapies in participants with advanced malignancies
• To assess the immunogenicity to AB598 in combination with zimberelimab and standard chemotherapies in participants with advanced malignancies
• To assess the clinical activity of AB598 in combination with zimberelimab and standard chemotherapies in participants with advanced malignancies