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ePoster Display

818TiP - Balstilimab alone or in combination with zalifrelimab as second-line treatment for patients with previously treated recurrent/metastatic cervical cancer (R/M CC): A randomized, placebo-controlled phase II trial (RaPiDS/GOG-3028)

Date

16 Sep 2021

Session

ePoster Display

Presenters

Leslie Randall

Citation

Annals of Oncology (2021) 32 (suppl_5): S725-S772. 10.1016/annonc/annonc703

Authors

L. Randall1, D. O'Malley2, C. Gunderson Jackson3, R.L. Coleman4, J. Hays5, K.N. Moore3, R.W. Naumann6, R. Rocconi7, B. Slomovitz8, K.S. Tewari9, M. Ancukiewicz10, W.I. Ortuzar Feliu10, B.J. Monk11

Author affiliations

  • 1 Division Of Gynecologic Oncology, Massey Cancer Center, Virginia Commonwealth University Medical College of Virginia Campus, 23298 - Richmond/US
  • 2 Division Of Gynecologic Oncology, The Ohio State University Wexner Medical Center and The James Comprehensive Cancer Center, 43210 - Columbus/US
  • 3 Department Of Obstetrics And Gynecology, Stephenson Oklahoma Cancer Center, University of Oklahoma Health Science Center, Oklahoma City/US
  • 4 Gynecologic Oncology, Texas Oncology–The Woodlands, 77380 - Houston/US
  • 5 Wexner Medical Center, The Ohio State University, 43210 - Columbus/US
  • 6 Obstetrics And Gynecology, Levine Cancer Institute, NC 28204 - Charlotte/US
  • 7 Gynecologic Oncology, University of South Alabama Mitchell Cancer Institute, 36688 - Mobile/US
  • 8 Sylvester Comprehensive Cancer Center, University of Miami Health Center, 33146 - Miami/US
  • 9 Department Of Obstetrics & Gynecology, University of California, Irvine/US
  • 10 Clinical Development, Agenus Inc, 2421 - Lexington/US
  • 11 Division Of Gynecologic Oncology, Arizona Oncology (US Oncology Network), Phoenix/US
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Abstract 818TiP

Background

For patients with R/M CC, treatment options beyond platinum-based chemotherapy are limited and typically administered without expectation of cure. Targeting the PD-1/PD-L1 immune checkpoint pathway has provided an important advance in the management of advanced CC, however opportunities remain to improve on current outcomes. Amongst these, dual blockade of the PD-1/PD-L1 and CTLA-4 immune checkpoints represents a rational therapeutic strategy, given this approach has been shown to be highly effective in multiple tumor types. Balstilimab (anti-PD-1) and zalifrelimab (anti-CTLA-4) are two new checkpoint inhibitors that have emerged as promising investigational agents for patients with R/M CC who have progressed after first-line, platinum-based chemotherapy.

Trial design

RaPiDS is a randomized, blinded, two-arm phase II trial evaluating the efficacy and safety of balstilimab administered as either monotherapy or in combination with zalifrelimab. Planned enrollment is 210 pts with a confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix, that has relapsed after a first-line, platinum-based regimen for advanced (recurrent, unresectable, or metastatic) disease. Patients are randomized 1:1 into two treatment arms to receive balstilimab with placebo as monotherapy (Arm 1) or with zalifrelimab as combination therapy (Arm 2). Treatment is administered for up to 24 months or until disease progression, unacceptable toxicity, or other criteria for trial withdrawal occur. The primary endpoint is objective response rate determined by an Independent Radiology Review Committee according to RECIST v1.1 and key secondary endpoints include safety, duration of response, progression-free survival, overall survival, and quality of life outcomes. Recruitment is ongoing with 65 patients enrolled as of May 1, 2021 at centers across the United States.

Clinical trial identification

NCT03894215.

Editorial acknowledgement

Legal entity responsible for the study

Agenus Inc.

Funding

Agenus Inc.

Disclosure

L. Randall: Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: Clovis; Financial Interests, Personal, Advisory Role: Eisai; Financial Interests, Personal, Advisory Role: EMD Serono; Financial Interests, Personal, Advisory Role: Genentech/Roche; Financial Interests, Personal, Advisory Role: GSK; Financial Interests, Personal, Advisory Role: GOG Foundation; Financial Interests, Personal, Advisory Role: Mersana; Financial Interests, Personal, Advisory Role: Merck; Financial Interests, Personal, Advisory Role: Myriad Genetics; Financial Interests, Personal, Advisory Role: OnTarget; Financial Interests, Personal, Advisory Role: Rubius; Financial Interests, Personal, Advisory Role: BluPrint Oncology; Financial Interests, Personal, Advisory Role: Products in Knowledge; Financial Interests, Institutional, Funding: Akeso Bio; Financial Interests, Institutional, Funding: Genentech; Financial Interests, Institutional, Funding: Merck. D. O'Malley: Financial Interests, Personal, Advisory Role: Agenus; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: GSK/Tesaro; Financial Interests, Personal, Advisory Role: ImmunoGen; Financial Interests, Personal, Advisory Role: BBI; Financial Interests, Personal, Advisory Role: Ambry; Financial Interests, Personal, Advisory Role: Janssen; Financial Interests, Personal, Advisory Role: Abbvie; Financial Interests, Personal, Advisory Role: Regeneron; Financial Interests, Personal, Advisory Role: Amgen; Financial Interests, Personal, Advisory Role: Novocure; Financial Interests, Personal, Advisory Role: Genentech/Roche; Financial Interests, Personal, Advisory Role: GOG Foundation; Financial Interests, Personal, Advisory Role: Iovance; Financial Interests, Personal, Advisory Role: Myriad Genetics; Financial Interests, Personal, Advisory Role: Eisai; Financial Interests, Personal, Advisory Role: Tarveda; Financial Interests, Personal, Advisory Role: Merck; Financial Interests, Personal, Advisory Role: SeaGen; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Mersana; Financial Interests, Personal, Advisory Role: Clovis; Financial Interests, Personal, Advisory Role: Rubis; Financial Interests, Personal, Advisory Role: Elevar; Financial Interests, Institutional, Funding: Agenus. K.N. Moore: Financial Interests, Personal, Advisory Role: Aravive; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: Eisai; Financial Interests, Personal, Advisory Role: Elevar; Financial Interests, Personal, Advisory Role: GSK/Tesaro; Financial Interests, Personal, Advisory Role: Genentech/Roche; Financial Interests, Personal, Advisory Role: ImmunoGen; Financial Interests, Personal, Advisory Role: Merck; Financial Interests, Personal, Advisory Role: Mersana; Financial Interests, Personal, Advisory Role: Myriad; Financial Interests, Personal, Advisory Role: OncXerna; Financial Interests, Personal, Advisory Role: Sorrento; Financial Interests, Personal, Advisory Role: VBL Therapeutics; Financial Interests, Personal and Institutional, Funding: PTC Therapeutics; Financial Interests, Personal and Institutional, Funding: Eli Lilly; Financial Interests, Personal and Institutional, Funding: Merck. R.W. Naumann: Financial Interests, Personal, Advisory Role: Agenus; Financial Interests, Personal, Advisory Role: Merck; Financial Interests, Personal, Advisory Role: GSK/Tesaro; Financial Interests, Personal, Advisory Role: Clovis; Financial Interests, Personal, Advisory Role: SutroBio; Financial Interests, Personal, Advisory Role: Eisai; Financial Interests, Personal, Advisory Role, Agenus Inc: SeaGen; Financial Interests, Institutional, Research Grant: Agenus ; Financial Interests, Institutional, Research Grant: BMS; Financial Interests, Institutional, Research Grant: Mersana; Financial Interests, Institutional, Research Grant: GSK/Tesaro; Financial Interests, Institutional, Research Grant: SutroBio. R. Rocconi: Financial Interests, Personal, Speaker’s Bureau: GSK; Financial Interests, Personal, Speaker’s Bureau: Clovis; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Gradalis, Inc; Financial Interests, Personal, Expert Testimony: Johnson & Johnson. K.S. Tewari: Financial Interests, Personal, Speaker’s Bureau: Merck; Financial Interests, Personal, Speaker’s Bureau: Eisai; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: GSK/Tesaro; Financial Interests, Personal, Speaker’s Bureau: Clovis; Financial Interests, Personal, Advisory Board: Abbvie; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Genentech; Financial Interests, Institutional, Research Grant: Agenus; Financial Interests, Institutional, Research Grant: Genentech; Financial Interests, Institutional, Research Grant: Clovis; Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Institutional, Research Grant: Regeneron. M. Ancukiewicz: Financial Interests, Personal, Full or part-time Employment: Agenus. W.I. Ortuzar Feliu: Financial Interests, Personal, Full or part-time Employment: Agenus; Financial Interests, Personal, Stocks/Shares: Agenus. B.J. Monk: Financial Interests, Personal, Advisory Role: Agenus; Financial Interests, Personal, Advisory Role: Akeso Bio; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: GenMad/SeaGen; Financial Interests, Personal, Advisory Role: Iovance; Financial Interests, Personal, Advisory Role: Merck; Financial Interests, Personal, Advisory Role: Puma; Financial Interests, Personal, Advisory Role: Roche/Genentech; Financial Interests, Personal, Advisory Role: GSK/Tesaro; Financial Interests, Personal, Leadership Role: GOG Foundation. All other authors have declared no conflicts of interest.

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