Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

This was intended to be a phase I/II study of Encorafenib, Binimetinib, and Nivolumab for treating participants with Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer. The study was terminated before Phase II was initiated. The study did not open Phase II for enrollment. PRIMARY OBJECTIVES: I. To describe overall response rate (ORR) upon treatment with encorafenib, binimetinib, and nivolumab in patients with BRAFV600E, microsatellite stable (MSS) metastatic colorectal cancer (mCRC). II. To determine the safety and tolerability of nivolumab, encorafenib, and binimetinib in patients with BRAFV600E, MSS mCRC. SECONDARY OBJECTIVES: I. To estimate median progression-free survival (PFS) upon treatment with encorafenib, binimetinib, and nivolumab. II. To estimate median overall survival (OS) upon treatment with encorafenib, binimetinib, and nivolumab. III. To estimate median time to response (TTR) upon treatment with encorafenib, binimetinib, and nivolumab. IV. To estimate median duration of response (DoR) upon treatment with encorafenib, binimetinib, and nivolumab. V. To estimate disease control rate (DCR) upon treatment with encorafenib, binimetinib, and nivolumab. EXPLORATORY (CORRELATIVE) OBJECTIVES: I. To assess genomic and immune changes upon treatment with encorafenib, binimetinib, and nivolumab in tumor tissue, blood and stool. II. To correlate genomic and immune changes upon treatment with encorafenib, binimetinib, and nivolumab in tumor tissue, blood and stool with radiographic response. III. To evaluate contrast-enhanced computed tomography (CT) imaging for disease burden that is not measurable by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) and to correlate location and patterns of metastatic disease with clinical outcomes. OUTLINE: Participants in received encorafenib orally (PO) once daily (QD) on days 1-28, binimetinib PO twice daily (BID) on days 1-28, and nivolumab intravenously (IV) on day 1. Cycles repeat every 28 days for a maximum of 24 cycles of treatment. If disease progression or recurrence occurs, treatment may be resumed outside of the context of the clinical trial. After completion of study treatment, patients are followed up at 30 and 100 days, then every 3 months thereafter. Only participants in Phase 1 were enrolled. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Colonic Neoplasms
  • Colorectal Neoplasms
  • Metastatic Colon Adenocarcinoma
  • Metastatic Colorectal Adenocarcinoma
  • Metastatic Microsatellite Stable Colorectal Carcinoma
  • Metastatic Rectal Adenocarcinoma
  • Rectal Neoplasms
  • 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

NCT number NCT04044430
Study type Interventional
Source University of California, San Francisco
Contact
Status Terminated
Phase Phase 1
Start date August 31, 2020
Completion date July 31, 2022

See also
  Status Clinical Trial Phase
Active, not recruiting NCT00826540 - Sorafenib and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer Phase 2
Completed NCT00025337 - Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated Phase 3
Terminated NCT01934179 - Telomere Length in Predicting Toxicity in Older Patients With Stage III-IV Colorectal Cancer Undergoing Chemotherapy N/A
Completed NCT01191684 - Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic Cancer Phase 1
Terminated NCT01238965 - Panobinostat and Fluorouracil Followed By Leucovorin Calcium in Treating Patients With Stage IV Colorectal Cancer Who Did Not Respond to Previous Fluorouracil-Based Chemotherapy Phase 1
Terminated NCT01285102 - Chemoembolization Using Irinotecan in Treating Patients With Liver Metastases From Metastatic Colon or Rectal Cancer Phase 1
Terminated NCT01233505 - Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors Phase 1
Completed NCT01037790 - Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer Phase 2
Completed NCT00551421 - Pertuzumab and Cetuximab in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer Phase 1/Phase 2
Completed NCT00407654 - VEGF Trap in Treating Patients With Previously Treated Metastatic Colorectal Cancer Phase 2
Terminated NCT00052585 - Gefitinib and Combination Chemotherapy in Treating Patients With Advanced or Recurrent Colorectal Cancer Phase 2
Completed NCT00023933 - Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Metastatic Colorectal Cancer Phase 1
Recruiting NCT04113096 - Dibenzyl Trisulphide (GUINEAHEN WEED) for Stage IV Cancer Early Phase 1
Terminated NCT00397878 - AZD0530 (NSC 735464) in Treating Patients With Previously Treated Metastatic Colon Cancer or Rectal Cancer Phase 2
Completed NCT00100841 - Phase II Trial of FOLFOX6, Bevacizumab and Cetuximab in Patients With Colorectal Cancer Phase 2
Completed NCT00028496 - Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer Phase 1
Active, not recruiting NCT01652196 - Aflibercept and FOLFOX6 Treatment for Previously Untreated Stage IV Colorectal Cancer Phase 2
Completed NCT01116687 - RO4929097 in Treating Patients With Metastatic Colorectal Cancer Phase 2
Completed NCT01126346 - Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC) N/A
Terminated NCT00087191 - EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer N/A