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A Two-arm, Randomized, Non-comparative, Phase 2 Trial of AGEN2034 (anti-PD-1) as a Monotherapy or Combination Therapy with AGEN1884 (anti-CTLA4) or with Placebo in Women with Recurrent Cervical Cancer (Second Line) - RaPiDS
This is a randomized, blinded, non-comparative, two-arm Phase 2 clinical trial to assess the efficacy and safety of AGEN2034 administered with placebo (Treatment Arm 1 - monotherapy) or with AGEN1884 (Treatment Arm 2 - combination therapy) for treatment of patients with advanced cervical cancer who relapsed or progressed after receiving first-line platinum-based chemotherapy. The study is not intended to compare the efficacy of the 2 experimental arms. Rather, the efficacy of each arm will be evaluated against its relevant historical controls as appropriate.
Primary Objective: To assess the Objective Response Rate(ORR) to the treatment of AGEN2034(anti PD-1) administered with placebo(Treatment Arm 1 -monotherapy), or with AGEN1884 (anti-CTLA4) (Treatment Arm 2 - combination therapy), defined as the binomial proportion of intent to treat(ITT) patients with best overall response(BOR) of complete response (CR) or partial response (PR), in women with recurrent/persistent/metastatic cervical cancer who have progressed following first-line therapy. BOR will be determined by the Independent Radiology Review Committee (IRRC), according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
AGEN1884 (); AGEN2034 (); Placebo ()