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Study of Cabozantinib and Nivolumab in Refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer | Clinical Trials | Clareo Health

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Study of Cabozantinib and Nivolumab in Refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer

A Phase II Study of Cabozantinib and Nivolumab in Refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer

NCT04963283•University of Colorado, Denver

View on ClinicalTrials.gov

Summary

Data from a prior phase II study of single agent cabozantinib in metastatic, refractory colorectal cancer (NCT03542877) combined with the compelling preclinical data in colorectal mouse models utilizing cabozantinib combined with nivolumab have led to this concept for a clinical trial to combine cabozantinib and nivolumab in patients with metastatic MSS CRC in the third line setting and beyond.

Detailed Description

This is an open-label, single-arm, 2-stage, phase II study of cabozantinib in combination with nivolumab in patients with refractory metastatic CRC. Up to 46 evaluable patients will be treated with cabozantinib 40 mg orally daily in combination with nivolumab 480 mg IV every 28 days. One cycle is defined as 28 days.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The subject has a histologic or cytologic diagnosis of colorectal adenocarcinoma that is metastatic or unresectable;
•* The patient either did not tolerate, is refractory to or progressed (or relapsed) following treatment with a fluoropyrimidine, irinotecan, oxaliplatin, and bevacizumab;
•* Prior epidermal growth factor inhibitor therapy is required for patients with left-sided, RAS wild-type tumors;
•* Patients must be microsatellite stable (MSS), microsatellite-low (MSI-L) or have proficient mismatch repair (pMMR;
•* Prior TAS-102 (Lonsurf) treatment is not required;
•* Patients must have known extended RAS and BRAF status as per local standard of practice;
•2. Measurable disease per RECIST v.1.1 as determined by the investigator;
•3. The subject has had an assessment of all known disease sites e.g. by computerized tomography (CT) scan and/or magnetic resonance imaging (MRI) within 28 days before the first dose of cabozantinib;
•4. The subject is ≥ 18 years old on the day of consent;
•5. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
+17 more criteria

Exclusion Criteria

•1. Known microsatellite-high (MSI-H) or deficient mismatch repair (dMMR) colorectal cancer.
•2. The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g. cytokines or antibodies) within 3 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment;
•3. Prior treatment with cabozantinib or other small molecule kinase inhibitors;
•4. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways;
•6. The subject has received any other type of investigational agent within 28 days before the first dose of study treatment;
•7. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before the first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment;
•8. The subject has prothrombin time (PT)/INR or partial thromboplastin time (PTT) test ≥ 1.3 x the laboratory ULN within 7 days before the first dose of study treatment;
•9. Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran). Direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:
•1. Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).
•2. Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor;
+25 more criteria

Locations (5)

University of Colorado Hospital

Aurora, Colorado, United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

UCHealth Harmony Campus

Fort Collins, Colorado, United States

UCHealth Family Medicine - Greeley

Greeley, Colorado, United States

UCHealth Medical Center of the Rockies

Loveland, Colorado, United States

Key Dates

Start Date

June 23, 2021

Primary Completion Date

February 9, 2026

Completion Date

February 9, 2026

Last Updated

February 10, 2026

Enrollment

ACTUAL participants

Conditions

Colorectal AdenocarcinomaColon CancerColon AdenocarcinomaRectum CancerRectal CancerRectal AdenocarcinomaColorectal Cancer

Interventions

Cabozantinib

DRUG

Nivolumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Cabozantinib and Nivolumab in Refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

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A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic MSS/MSI-L Colorectal Cancer