COMbination of Bipolar Androgen Therapy and Nivolumab in Patients with Metastatic Castration-Resistant Prostate Cancer [COMBAT-CRPC]
Johns Hopkins Kimmel Cancer Center in Baltimore
To determine the PSA response rate to Bipolar Androgen Therapy + Nivolumab in men with Metastatic Castrate-Resistant Prostate Cancer (mCRPC) who have progressed on at least one prior second generation androgen receptor targeted therapies (i.e. abiraterone acetate, enzalutamide). Up to one taxane chemotherapy for mCRPC is permitted.
Adult male greater than 18 years of age. Histologic or cytologic diagnosis of adenocarcinoma of the prostate. Known castration-resistant disease, defined according to PCWG3 criteria: Castrate serum testosterone level: equal to 50 ng/dL ( equal to 1.7 nmol/L); Subjects who have failed initial hormonal therapy, either by orchiectomy or by using a GnRH agonist in combination with an anti-androgen, (must first progress through anti-androgen withdrawal prior to being eligible, minimum timeframe to document failure of anti-androgen withdrawal will be four weeks); Serum PSA progression defined as two consecutive increases in PSA over a previous reference value within 6 months of first study treatment, each measurement at least one week apart. Serum PSA at screening equal to 2 ng/mL; OR documented bone lesions by the appearance of equal to 2 new lesions by bone scintigraphy or soft tissue metastatic lesion assessed by CT or MRI. Must have PSA and/or radiographic progression on AT LEAST ONE novel AR targeted therapy (abiraterone acetate, enzalutamide). No limit on the maximum number or types of prior hormonal therapies received. Life expectancy greater than 6 months; ECOG performance status less than 2. Acceptable routine labs. At least 4 weeks since prior surgery with full recovery (no persistent toxicity).
Clinic visits every cycle (one time per month) for assessment of toxicity, physical exam, vital signs, and receipt of study treatment. Routine complete chemistry panel, complete blood count w/ diff, PSA, and serum testosterone labs performed every cycle. CT and NM Bone scans performed every 3 months for restaging. Mandatory biopsies to be performed at screening and cycle 4 day 1, with an optional biopsy to be performed at the off-treatment visit depending on patient consent.
08/08/2020 05:02 AM