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Cabozantinib and Immunotherapy for Gastrointestinal Cancers

This study is testing combinations of cabozantinib, durvalumab, and tremelimumab for people with advanced gastric, esophageal, colorectal, or liver cancer. Researchers want to see how safe these drug combinations are and how well they work. Cabozantinib is taken by mouth, while durvalumab and tremelimumab are given through an IV (infusion). The study aims to find the highest safe dose and measure how many people respond to the treatment. You may be able to join if you are 18 or older and have one of these cancer types. This is an open-label study, meaning you and your doctors will know which treatment you are receiving. The study plans to enroll about 117 participants.

Study design
This is a Phase I/II, open-label study planning to enroll about 117 participants. It is testing drug combinations in different groups of patients.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how well the treatment works every 8 weeks for 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03539822

Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies

Recruiting
PHASE1Ages 18+InterventionalTreatment
Anwaar Saeed
~117 participants
Updated 2026-01-21 on ClinicalTrials.gov
What's tested:CabozantinibDurvalumabTremelimumab

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I- Maximum Tolerated Dose (MTD)
Measured over 9 months
+1 more outcome measured

Conditions

Gastric Cancer
Esophageal Adenocarcinoma
Hepatocellular Carcinoma
Colorectal Cancer

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NCT03539822

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvaniastudy coordinator listed

    Recruiting

  • University of Kansas Cancer Center

    Westwood, Kansasno site contact published

    Terminated

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Anwaar Saeed, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

Who to contact

Debra Diecks, RN
[email protected]
4126238364
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Esophageal adenocarcinoma
Colorectal adenocarcinoma (CRC)
Hepatocellular carcinoma (HCC) 4. Patients should have advanced (stage 4) or locally unresectable (stage III) disease. 5. Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 6. Patients must consent to undergo a required screening/baseline biopsy procedure (and potentially another tumor biopsy at time of disease response and progression) for correlative testing. 7. Patients with gastric, gastroesophageal, or esophageal adenocarcinoma must show evidence of progression or intolerance to at least one previous standard of care systemic therapy. 8. Patients with CRC must show evidence of progression or intolerance to at least 2 previous standard of care systemic therapy. Ras wild type patients should fail epidermal growth factor receptor (EGFR) monoclonal antibody (panitumumab or cetuximab) to be eligible.

Exclusion

Malignancy treated with curative intent/ resection and with no known active disease before the first dose of investigational product (IP) and of low potential risk for recurrence.
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
Adequately treated carcinoma in situ without evidence of disease.

What this trial measures

  • Phase I- Maximum Tolerated Dose (MTD)9 months

    Defined as the highest dose studied for which the observed incidence of dose limiting toxicities (DLT) is less than 33%. Determined per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  • Phase II- Overall Response Rate (ORR)Every 8 weeks for 12 months

    Defined as the proportion of participants best response to treatment. Per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.