Clinical Trials Actively Recruiting

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.

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).

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.

Primary Objective (Phase 1):

• To evaluate the safety and tolerability of escalating dose levels of EG-70 administered by intravesical instillation in patients with BCG-unresponsive NMIBC who are scheduled for, refuse, or are ineligible for radical cystectomy.

Secondary Objectives (Phase 1):

• To identify an RP2D.
• To evaluate preliminary efficacy of EG-70 by 12 weeks.

Primary Objectives (Phase 2):

• To evaluate efficacy of EG-70 (determined by complete response [CR]) at 48 weeks in each cohort separately.
• To evaluate the safety of the RP2D of EG-70 administered by intravesical instillation in patients with BCG-unresponsive NMIBC and patients with high-risk NMIBC who are BCG-naïve or have received incomplete BCG treatment.

Secondary Objectives (Phase 2):

• To evaluate disease-free survival rate in each cohort separately.
• To evaluate CR at the efficacy analysis following each cycle and the duration of CR in each cohort separately.

Primary Objectives:

• To characterize the safety and tolerability of different dose levels of ZL-1218 when administered as a single agent and in combination with pembrolizumab (200 mg IV Q3 week), including dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended dose (RD) of ZL-1218.

Secondary Objectives:

• To assess the preliminary efficacy of ZL-1218 when administered as a single agent and in combination with pembrolizumab.
• To characterize the pharmacokinetics (PK) of ZL-1218 as a single agent or in combination with pembrolizumab, after a single dose and multiple doses.
• To evaluate the immunogenicity of ZL-1218 as a single agent or in combination with pembrolizumab, after a single dose and multiple doses.

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.

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

Part A

Primary Objectives:

• To characterize the safety and tolerability of GV20-0251 and establish the MTD and/or the RP2D of GV20-0251

Secondary Objectives:

• To characterize the PK of GV20-0251
• To characterize the immunogenicity of antiGV20-0251 ADA and nADA
• To evaluate the preliminary anti-tumor activity of GV20-0251

Part B

Primary Objectives:

• To evaluate the ORR per RECIST version 1.1 of GV20-0251 in different tumor types

Secondary Objectives:

• To characterize the safety of GV20-0251
• To characterize the PK of GV20-0251
• To characterize the immunogenicity of GV20-0251
• To evaluate the anti-tumor activity of GV20-0251

Phase 1 Dose Finding

Primary Objectives:

• To assess the safety and tolerability of gedatolisib in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC)
• To determine the recommended Phase 2 dose (RP2D) of gedatolisib in combination with darolutamide in mCRPC
• To compare the Bayesian Optimal Interval (BOIN) utility score between the 2 arms

Phase 2 Dose Expansion

Primary Objectives:

To assess the antitumor activity of gedatolisib in combination with darolutamide in each arm as demonstrated by radiographic progression-free survival (rPFS) by arm

Secondary Objectives: