Regorafenib, Ipilimumab and Nivolumab for the Treatment of Chemotherapy Resistant Microsatellite Stable Metastatic Colorectal Cancer
Part of paid clinical trials in Duarte, California.
- Sponsor
- City of Hope Medical Center
- Study ID
- NCT04362839
- Phase
- PHASE1
- Status
- Completed
Conditions
- Advanced Colon Adenocarcinoma
- Metastatic Colon Adenocarcinoma
- Metastatic Colorectal Adenocarcinoma
- Metastatic Colorectal Carcinoma
- Metastatic Rectal Adenocarcinoma
- Stage III Colon Cancer AJCC v8
- Stage III Rectal Cancer AJCC v8
- Stage IIIA Colon Cancer AJCC v8
- Stage IIIA Rectal Cancer AJCC v8
- Stage IIIB Colon Cancer AJCC v8
- Stage IIIB Rectal Cancer AJCC v8
- Stage IIIC Colon Cancer AJCC v8
- Stage IIIC Rectal Cancer AJCC v8
- Stage IV Colon Cancer AJCC v8
- Stage IV Colorectal Cancer AJCC v8
- Stage IV Rectal Cancer AJCC v8
- Stage IVA Colon Cancer AJCC v8
- Stage IVA Colorectal Cancer AJCC v8
- Stage IVA Rectal Cancer AJCC v8
- Stage IVB Colon Cancer AJCC v8
- Stage IVB Colorectal Cancer AJCC v8
- Stage IVB Rectal Cancer AJCC v8
- Stage IVC Colon Cancer AJCC v8
- Stage IVC Colorectal Cancer AJCC v8
- Stage IVC Rectal Cancer AJCC v8
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ipilimumab — BIOLOGICALGiven IV
- Nivolumab — BIOLOGICALGiven IV
- Regorafenib — DRUGGiven PO
Study Details
This phase I trial studies the side effects and best dose of regorafenib when given together with ipilimumab and nivolumab in treating patients with microsatellite stable colorectal cancer that has spread to other places in the body (metastatic) and remains despite chemotherapy treatment (resistant). Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as ipilimumab and 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 regorafenib, ipilimumab and nivolumab may slow the tumor growth and/or shrink the tumor size in patients with colorectal cancer.
Key Dates
- Start date
- May 27, 2020
- Status verified
- Jan 2026
- Primary completion
- Dec 11, 2025
- Completion
- Dec 11, 2025
Study Design
- Enrollment
- 39 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (regorafenib, nivolumab, ipilimumab)Patients receive regorafenib PO QD on days 1-21, nivolumab IV over 30 minutes Q2W, and ipilimumab IV over 30 minutes Q6W. Cycles repeat every 28 day for up to 2 years in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Recommended dose level of the combination [ Time Frame: Up to 90 days post treatment ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | - |
Find similar trials in Duarte, CA
Related Studies
- Radiation Therapy for the Treatment of Metastatic Gastrointestinal CancersRecruiting · University of California, San Francisco · San Francisco, California
- PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric CancerPHASE1 · Recruiting · City of Hope Medical Center · Duarte, California
- Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal CancerPHASE1 · Recruiting · Jonsson Comprehensive Cancer Center · Los Angeles, California
- Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, The ERASur StudyPHASE3 · Recruiting · Alliance for Clinical Trials in Oncology · Kingman, Arizona