NCT04943627 is a Phase 3 clinical trial of Balstilimab (BAL) in Advanced Cancer, sponsored by Agenus Inc..

Who is sponsoring NCT04943627?

NCT04943627 is sponsored by Agenus Inc..

What drugs are being tested in NCT04943627?

Interventions in NCT04943627: Balstilimab (BAL), Topotecan, Vinorelbine, Gemcitabine, Irinotecan, Pemetrexed.

What condition does NCT04943627 study?

NCT04943627 studies Advanced Cancer, Metastatic Cervical Cancer.

Is NCT04943627 still recruiting?

NCT04943627 is currently withdrawn. Last updated 5 October 2022.

Last reviewed 2022-10-05 · How we verify

NCT04943627

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Balstilimab Versus Investigator Choice Chemotherapy in Patients With Recurrent Cervical Cancer (BRAVA)

Withdrawn Phase 3 Last updated 5 October 2022

What this trial tests

Phase 3 trial testing Balstilimab (BAL) in Advanced Cancer. Withdrawn.

Timeline

2 August 2021

Primary endpoint
22 October 2021

22 October 2021

Quick facts

Lead sponsor	Agenus Inc.
Phase	Phase 3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	2 August 2021
Primary completion	22 October 2021
Estimated completion	22 October 2021
Sites	3 locations across United States, Armenia

Drugs / interventions tested

Balstilimab (BAL)
Topotecan (topotecan) — full drug profile →
Vinorelbine
Gemcitabine (gemcitabine) — full drug profile →
Irinotecan (irinotecan) — full drug profile →
Pemetrexed — full drug profile →

Conditions studied

Advanced Cancer — all drugs for Advanced Cancer →
Metastatic Cervical Cancer — all drugs for Metastatic Cervical Cancer →

Sponsor

Agenus Inc. — full company profile →

Who can join

18 and older, female only, with Advanced Cancer or Metastatic Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This Phase 3 trial is an open-label, randomized study with single-agent Balstilimab (BAL) or Investigator Choice (IC) chemotherapy (single-agent gemcitabine, irinotecan, pemetrexed, vinorelbine, or topotecan) in patients with recurrent, persistent, or metastatic cervical cancer who have progressed after receiving platinum based chemotherapy.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Dual PD-1 and CTLA-4 Checkpoint Blockade Using Balstilimab and Zalifrelimab Combination as Second-Line Treatment for Advanced Cervical Cancer: An Open-Label Phase II Study.
O'Malley DM, Neffa M, Monk BJ, Melkadze T, et al · · 2022 · cited 140× · PMID 34932394 · DOI 10.1200/jco.21.02067
Advances in immunotherapy for cervical cancer.
Grau-Bejar JF, Garcia-Duran C, Garcia-Illescas D, Mirallas O, et al · · 2023 · cited 31× · PMID 37007635 · DOI 10.1177/17588359231163836
PD-1/PD-L1 inhibitors for advanced or metastatic cervical cancer: From bench to bed.
Huang W, Liu J, Xu K, Chen H, et al · · 2022 · cited 30× · PMID 36313730 · DOI 10.3389/fonc.2022.849352
Immune checkpoint blockade for locally advanced or recurrent/metastatic cervical cancer: An update on clinical data.
Song Z, Zou K, Zou L. · · 2022 · cited 10× · PMID 36644634 · DOI 10.3389/fonc.2022.1045481
Immunotherapy in cervical cancer: From the view of scientometric analysis and clinical trials.
Xing Y, Yasinjan F, Du Y, Geng H, et al · · 2023 · cited 9× · PMID 36817443 · DOI 10.3389/fimmu.2023.1094437
Targeting immune microenvironment in cervical cancer: current research and advances.
Zhang Z, Liu M, An Y, Gao C, et al · · 2025 · cited 6× · PMID 40781691 · DOI 10.1186/s12967-025-06896-3

Verify or expand the search:

Other recruiting trials for Advanced Cancer

Currently open trials in the same condition.

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NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
NCT07246954 — A Chaplain-clinician Led Spiritual Care (PEACE) Intervention on Spiritual/Religious Beliefs Related to Medical Care in P · NA · recruiting
NCT06346197 — Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas · Phase 3 · recruiting
NCT07147023 — Better Real-time Information on Documentation of Goals of Care for Engagement in Serious Illness Communication · NA · active not recruiting

Other Agenus Inc. trials

Trials by the same sponsor.

NCT05630183 — A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer · Phase 2 · active not recruiting
NCT05377528 — Study of AGEN1571 in Participants With Advanced Solid Tumors · Phase 1 · completed
NCT05025085 — A Study Investigating AGEN1777 in Participants With Advanced Solid Tumors · Phase 1 · completed
NCT05033132 — A Phase II Study of Balstilimab Independently or in Combination With Zalifrelimab in Advanced Cervical Cancer · Phase 2 · withdrawn
NCT04156100 — A Study in Subjects With Advanced Solid Tumors · Phase 1 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04943627 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Agenus Inc.
Last refreshed: 5 October 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04943627.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing