NCT03539822 · Anwaar Saeed
Cabozantinib Plus Durvalumab with or Without Tremelimumab in Patients with Gastroesophageal Cancer and Other Gastrointestinal Malignancies
(CAMILLA)
What this study is about
The investigators propose to evaluate the safety of drug combinations in patients with advanced gastroesophageal cancer and other gastrointestinal (GI) malignancies. Finding effective novel therapies for patients with advanced gastric cancer and other GI malignancies is an area of great unmet need.
View original scientific description
The investigators propose to evaluate the safety of drug combinations in patients with advanced gastroesophageal cancer and other gastrointestinal (GI) malignancies. Finding effective novel therapies for patients with advanced gastric cancer and other GI malignancies is an area of great unmet need.
Interventions
DRUG
Cabozantinib
by mouth
DRUG
Durvalumab
infusion
DRUG
Tremelimumab
infusion
Primary outcome measures
Phase I- Maximum Tolerated Dose (MTD)
Time frame: 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)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age ≥ 18 years 2. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 3. Histologically confirmed diagnosis of any of the following:
- Gastric or gastroesophageal junction adenocarcinoma
- 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 sta
Where
- Westwood, Kansas
- Pittsburgh, Pennsylvania
Collaborators
AstraZeneca, Exelixis
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 21, 2026 · Source of record for eligibility and locations