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 Objectives:

• To identify the maximum tolerated dose (MTD) and/ or recommended Phase 2 dose (RP2D), and evaluate the safety, tolerability and dose-limiting toxicities (DLTs) of HC-7366 in combination with belzutifan in patients with locally advanced or metastatic RCC with predominantly clear cell histology (ccRCC), irrespective of VHL gene mutation status (combination only).

Secondary Objectives:

• To assess the potential antitumor activity of HC-7366 in combination with belzutifan by response, disease stabilization, and survival outcomes by assessing:
  • 1. Overall response rate (ORR) per RECIST v1.1
  • 2. Duration of response (DOR)
  • 3. Disease control rate (DCR: CR or PR or stable disease)
  • 4. Time to Response (TTR)
  • 5. Median progression free survival (PFS) and PFS at six months
  • 6. Median overall survival (OS) and 1-yr OS
• To determine the plasma concentration and PK parameters following single and multiple doses of HC-7366 alone or in combination with belzutifan administered to patients with locally advanced or metastatic RCC with predominantly clear cell histology, irrespective of VHL gene mutation status (PK parameters of both HC-7366 and belzutifan will be measured)
• To characterize HC-7366 monotherapy and in combination with belzutifan in patients with ccRCC

Primary Objectives:

• To compare DFS between Group A and Group B

Secondary Objectives:

• To compare TTNT (local or systemic) between study treatments
• To compare HG RFS between study treatments
• To compare PFS between study treatments
• To compare the rate of diagnostic and therapeutic invasive urological interventions after study treatment
• To assess safety and tolerability
• To compare OS between study treatments
• To compare participant-reported disease- and treatment-related symptoms and impacts on functioning between study treatments

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 AB598 in participants with advanced malignancies

Secondary Objectives:

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

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.

PHASE 1

Primary Objectives:

• Assess safety and tolerability of NUV‑1511 in advanced solid tumors
• Identify recommended dosing schedule(s) and corresponding RP2D(s) for Phase 2

Secondary Objectives:

• Explore preliminary efficacy of NUV-1511
• Characterize the PK profiles of NUV-1511

PHASE 2

Primary Objectives:

• Evaluate the efficacy of NUV-1511 in advanced solid tumors and selected tumor type(s)
• Confirm the optimal NUV-1511 dosing schedule, dose level, and target tumor types for further development

Secondary Objectives:

• Further evaluate the safety and efficacy of NUV-1511

Primary Objectives:

• To assess the utility of PYLARIFY PET in identifying men with FIR prostate cancer who have higher risk disease based on PYLARIFY PET imaging

Secondary Objectives:

• To assess impact of PYLARIFY PET findings on intended patient clinical management in men with FIR prostate cancer
• To determine the true detection rate (TDR) of PYLARIFY PET at a patient level in the detection of extraprostatic extension, seminal vesicle invasion, regional lymph node involvement and/or distant metastases in men with FIR prostate cancer
• To determine the correct localization rate (CLR) of PYLARIFY PET at a patient level in the detection of extraprostatic extension, seminal vesicle invasion, regional lymph node involvement and/or distant metastases in men with FIR Prostate cancer
• To determine the positive predictive value (PPV) of PYLARIFY PET at a patient level in the detection of extraprostatic extension, seminal vesicle invasion, regional lymph node involvement and/or distant metastases in men with FIR prostate cancer
• To calculate the sensitivity, specificity and negative predictive value (NPV) of PYLARIFY PET at a patient level in the detection of extraprostatic extension, seminal vesicle invasion and/or regional lymph node involvement in men with FIR prostate cancer
• To assess the safety and tolerability of PYLARIFY PET in in men with FIR prostate cancer