Encorafenib, Binimetinib, and Nivolumab in Treating Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer
NCT04044430 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2023-01-09
Summary
This phase I/II trial studies the side effects and how well encorafenib, binimetinib, and nivolumab work in treating patients with microsatellite stable, BRAFV600E gene-mutated colorectal cancer that has spread to other places in the body (metastatic). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving encorafenib, binimetinib, and nivolumab may work better in treating patients with colorectal cancer compared to standard treatments.
Conditions
- Metastatic Colon Adenocarcinoma
- Metastatic Colorectal Adenocarcinoma
- Metastatic Microsatellite Stable Colorectal Carcinoma
- Metastatic Rectal Adenocarcinoma
- Stage III Colon Cancer
- Stage III Colorectal Cancer
- Stage III Rectal Cancer
- Stage IIIA Colon Cancer
- Stage IIIA Colorectal Cancer
- Stage IIIA Rectal Cancer
- Stage IIIB Colon Cancer
- Stage IIIB Colorectal Cancer
- Stage IIIB Rectal Cancer
- Stage IIIC Colon Cancer
- Stage IIIC Colorectal Cancer
- Stage IIIC Rectal Cancer
- Stage IV Colon Cancer
- Stage IV Colorectal Cancer
- Stage IV Rectal Cancer
- Stage IVA Colon Cancer
- Stage IVA Colorectal Cancer
- Stage IVA Rectal Cancer
- Stage IVB Colon Cancer
- Stage IVB Colorectal Cancer
- Stage IVB Rectal Cancer
- Stage IVC Colon Cancer
- Stage IVC Colorectal Cancer
- Stage IVC Rectal Cancer
Interventions
- DRUG
-
Binimetinib
Given PO
- DRUG
-
Given PO
- BIOLOGICAL
-
Given IV
- OTHER
-
Questionnaire Administration
Ancillary studies
Sponsors & Collaborators
- collaborator INDUSTRY
- collaborator INDUSTRY
-
University of California, San Francisco
lead OTHER
Principal Investigators
-
Chloe E Atreya, MD, PhD · University of California, San Francisco
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-31
- Primary Completion
- 2022-07-31
- Completion
- 2022-07-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Envafolimab Combined With Trifluridine/Tipiracil and Bevacizumab in the Treatment of Refractory mCRC.
NCT06060704 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
NCT04607421 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer
NCT03693170 ·Status: COMPLETED ·Phase: PHASE2
-
Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer
NCT04117945 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Guadecitabine and Nivolumab in Treating Refractory Metastatic Colorectal Cancer
NCT03576963 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
PhII Trial Panitumumab, Nivolumab, Ipilimumab in Kras/Nras/BRAF Wild-type MSS Refractory mCRC
NCT03442569 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 2, Single-arm Trial of BMS-986340 in Association With Nivolumab, Trifluridine/Tipiracil and Bevacizumab for Patients Refractory to Standard of Care Treatment and With Microsatellite-stable Colorectal Cancer
NCT07011550 ·Status: SUSPENDED ·Phase: PHASE2
-
Study of Cabozantinib and Nivolumab in Refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer
NCT04963283 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
SX-682 and Nivolumab for the Treatment of RAS-Mutated, MSS Unresectable or Metastatic Colorectal Cancer, the STOPTRAFFIC-1 Trial
NCT04599140 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer
NCT06102902 ·Status: SUSPENDED ·Phase: PHASE1
-
Combination Therapy for BRAF-V600E Metastatic CRCm
NCT06411600 ·Status: RECRUITING ·Phase: PHASE2
-
Nimotuzumab Combined With Trifluridine/Tipiracil in the Treatment of Refractory Metastatic Colorectal Cancer
NCT06343116 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Vemurafenib and Panitumumab Combination Therapy in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer
NCT01791309 ·Status: COMPLETED ·Phase: PHASE1
-
Encorafenib Plus Cetuximab in a Neoadjuvant Setting in Patients With BRAF Mutation Localised Colon or Upper Rectum Cancer
NCT05706779 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer
NCT05217446 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors
NCT02636036 ·Status: COMPLETED ·Phase: PHASE1
-
Neoadjuvant Encorafenib, Binimetinib and Cetuximab for Patients With BRAF V600E Mutated/pMMR Localized Colorectal Cancer
NCT05510895 ·Status: COMPLETED ·Phase: PHASE2
-
Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer
NCT03983993 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
VB-111 in Combination With Nivolumab in People With Metastatic Colorectal Cancer (mCRC)
NCT04166383 ·Status: TERMINATED ·Phase: PHASE2
-
Erlotinib, Modified FOLFOX6, and Bevacizumab as First-Line Therapy Metastatic Colorectal Cancer
NCT00118261 ·Status: COMPLETED ·Phase: PHASE1
-
Study on the Effectiveness and Safety of the Combination of the Two Drugs Regorafenib and Nivolumab in Patients With Colorectal Cancer (Cancer of the Colon or Rectum Classified as Proficient Mismatch Repair and Microsatellite Stable)
NCT04126733 ·Status: COMPLETED ·Phase: PHASE2
-
An Open Label Study Evaluating the Efficacy and Safety of Etrumadenant (AB928) Based Treatment Combinations in Participants With Metastatic Colorectal Cancer.
NCT04660812 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.
NCT05270044 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer
NCT05710406 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2/PHASE3
-
Combination Chemotherapy and Cetuximab or Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
NCT01280643 ·Status: TERMINATED ·Phase: NA