Advanced Cancer Clinical Trial
Official title:
A Phase 3 Trial of Balstilimab Versus Investigator Choice Chemotherapy in Patients With Recurrent Cervical Cancer After Platinum-Based Chemotherapy (BRAVA)
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.
The purpose of this Phase 3 trial is to demonstrate prolongation of OS in patients treated with BAL as compared to IC chemotherapy. This Phase 3 trial is an open-label, randomized study with single-agent BAL or 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. Population: Patients with recurrent, unresectable, or metastatic cervical cancer who have progressed after receiving at least 1 prior line of platinum-containing chemotherapy with or without bevacizumab. In this study, > 50% of patients will have received prior treatment with bevacizumab, which will be determined prior to enrollment. Stratification - Histology (squamous cell carcinoma [SCC] vs adenocarcinoma [AC] or adenosquamous carcinoma [ASC]) - Region of the world (United States or Europe Union or Australia vs other countries) - Eastern Cooperative Oncology Group (ECOG) status 0 vs 1 Randomization • 2:1, BAL: IC chemotherapy Approximately 486 patients will be enrolled and randomized with 2:1 allocation between the BAL and IC chemotherapy arms. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03181854 -
Randomized Controlled Trial of Integrated Early Palliative Care
|
N/A | |
| Completed |
NCT01197170 -
Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance
|
Phase 1 | |
| Recruiting |
NCT05045040 -
Empathetic Communication Facilitation Program for Early Initiation of End-of-life Discussions
|
N/A | |
| Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03994601 -
An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
| Completed |
NCT01393990 -
A Study of LY2228820 in Participants With Advanced Cancer
|
Phase 1 | |
| Completed |
NCT02857270 -
A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
|
Phase 1 | |
| Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT04121676 -
Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT03177291 -
Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC
|
Phase 1 | |
| Completed |
NCT03980041 -
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
|
Phase 2 | |
| Active, not recruiting |
NCT03674567 -
Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04823377 -
Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
|
N/A | |
| Completed |
NCT02778126 -
A Study of Prexasertib (LY2606368) in Participants With Advanced Cancer
|
Phase 1 | |
| Completed |
NCT02529553 -
A Study of LY3076226 in Participants With Advanced or Metastatic Cancer
|
Phase 1 | |
| Completed |
NCT02507544 -
A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer
|
Phase 1 | |
| Completed |
NCT02245204 -
Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers
|
Phase 1 | |
| Completed |
NCT01901237 -
Yoga for Adolescent and Young Adult Non-Curative Cancer Patients
|
N/A | |
| Completed |
NCT01583777 -
Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer
|
Phase 1 |