Atezolizumab plus tivozanib for immunologically cold tumor types: the IMMCO-1 trial.
Brian H Ramnaraign, Ji-Hyun Lee, Azka Ali...
https://pubmed.ncbi.nlm.nih.gov/36399037Actively Recruiting
Phase 1
Phase 2
Age: 18Years - 99Years
All Genders
ID05000294
Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types
Led by University of Florida · Updated on 2026-06-05
29
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of atezolizumab, an immune checkpoint inhibitor, and tivozanib, a VEGF tyrosine kinase inhibitor, in patients with various "immunologically cold" tumors. These tumor types, including prostate, biliary tract, soft tissue sarcomas, well-differentiated neuroendocrine tumors, microsatellite stable colorectal cancer, pancreatic cancer, and certain breast cancers, typically show low response rates to immunotherapy alone. The study aims to explore whether inhibiting VEGF can improve the immune response and effectiveness of checkpoint blockade in these cancers. Participants in this Phase 1b and Phase 2 study receive atezolizumab intravenously at 1680 mg on the first day of each 28-day cycle. Tivozanib is taken orally once daily from days 1 to 21 of each cycle. Dose levels for tivozanib are assigned during Phase 1b, with doses of either 1.34 mg/day or 0.89 mg/day, while Phase 2 participants receive 0.89 mg/day. This combination treatment is being studied to assess its effects on these difficult-to-treat cancers. During the trial, participants undergo evaluations including imaging and laboratory tests to measure tumor response and monitor safety. The primary outcome measured is the objective response rate over 30 months, with secondary outcomes including progression-free survival, overall survival, and disease control rate within the same period. The study requires patients to have measurable disease and adequate organ function, and includes monitoring for adverse events and treatment adherence throughout the study duration.
CONDITIONS
Brief Title
Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types
Who Can Participate
Age: 18Years - 99Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of stage IV immunologically cold or incurable cancer of specific types including bile duct, gallbladder, metastatic breast (HR-negative HER2-positive), neuroendocrine (grade 2 or 3), high grade ovarian, pancreatic adenocarcinoma, soft tissue sarcoma, castrate-resistant prostate cancer, or vulvar cancer
- At least one prior systemic treatment for advanced or metastatic disease, or no standard therapies with significant benefit
- ECOG Performance Status less than or equal to 1 for phase 1b or less than or equal to 2 for phase 2
- Measurable disease by RECIST criteria
- Adequate hematologic and organ function
- Stable anticoagulation therapy if applicable
- Negative hepatitis B surface antigen and HIV test with specific conditions for positive HIV cases
- Use of adequate contraception for women of childbearing potential and males with partners of childbearing potential
- Life expectancy of at least 12 weeks
- Ability and willingness to provide informed consent and comply with study procedures
- Availability of recent tissue samples for research
- Ability to swallow capsules
You will not qualify if you...
- Known MSI-H or dMMR tumor status
- Severe uncontrolled hypertension
- Prior treatment with VEGFR tyrosine kinase inhibitors
- Unwillingness or inability to use contraception if applicable
- Pregnant or breastfeeding women
- History of leptomeningeal disease
- Uncontrolled hypercalcemia or tumor-related pain
- Frequent drainage needs for pleural, pericardial effusion, or ascites except specific ovarian cancer cases
- Active or history of severe autoimmune diseases with some exceptions
- History or evidence of pneumonitis or radiation pneumonitis
- Active tuberculosis
- Significant recent cardiovascular disease
- Recent major surgery
- Recent history of other malignancies except certain low-risk types
- Recent severe infections
- Recent therapeutic antibiotics use except prophylactic
- Prior allogeneic stem cell or solid organ transplantation
- Current hepatitis B antiviral therapy
- Recent investigational therapy
- Prior immune checkpoint blockade or CD137 agonist therapies
- Recent immunostimulatory or immunosuppressive treatments with exceptions
- History of severe allergic reactions to similar antibodies
- Known hypersensitivity to atezolizumab components
- Other diseases or conditions that contraindicate study therapy per physician
- Recent live virus vaccination
- Prisoners or involuntarily incarcerated individuals
- Tumor Mutation Burden of 10 or higher
- Recent cancer-directed therapy
- Untreated or unstable brain metastases
- Inability to stop contraindicated medications
- Significant proteinuria or abnormal QTc interval or ECG abnormalities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive Atezolizumab intravenously on Day 1 of each 28-day cycle and take Tivozanib orally once daily on Days 1 through 21 of each cycle.
1 visit per 28-day cycle (in-person)
Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
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Research Team
J
Jamie Knapp
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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