Study on the Effectiveness and Safety of Various Immunotherapy Combinations for Advanced Liver Cancers (Morpheus-Liver)
Sponsor: Hoffmann-La Roche
ClinicalTrials ID:NCT04524871
This clinical trial is exploring different combinations of immunotherapy treatments to see how well they work and how safe they are for patients with advanced liver cancers. The study is flexible, allowing new treatments to be added or changed as needed.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is designed to test different combinations of immunotherapy treatments in patients with advanced liver cancers. It is an open-label, multicenter study, meaning that both the researchers and participants know which treatments are being given. The study can adapt by adding new treatment options or changing existing ones based on their effectiveness and safety. Participants with advanced liver cancer will be randomly assigned to different treatment groups. If a treatment is not effective or causes too many side effects, participants may switch to a different treatment option.
Eligibility Criteria
Inclusion Criteria
Stage 1
- Must be in good overall health with a performance status score of 0 or 1.
- Have advanced liver cancer that cannot be removed by surgery.
- Have not received any previous systemic treatment for liver cancer.
- Have a life expectancy of at least 3 months.
- Provide a tumor sample for testing.
Stage 1 and Stage 2
- Have measurable disease based on specific criteria.
- Have good blood and organ function.
- Have documented hepatitis status.
- Test negative for HIV.
- Agree to use contraception if of childbearing potential.
Stage 2
- Must be in good overall health with a performance status score of 0, 1, or 2.
- Able to start Stage 2 treatment within 3 months if needed.
- Provide a tumor sample from a biopsy if possible.
NKT2152-Containing Arm:
- Have specific liver function test results within acceptable limits.
Exclusion Criteria
Stage 1
- Have had certain previous treatments or therapies.
- Have untreated or high-risk esophageal or gastric varices.
- Have unresolved side effects from previous cancer treatments.
- Have uncontrolled high blood pressure or significant vascular disease.
- Have had recent bleeding or certain medical conditions.
- Have had recent major surgery or procedures.
- Have certain other medical conditions or treatments.
Stage 1 and 2
- Have specific types of liver cancer or other medical conditions.
- Have uncontrolled pain or fluid buildup.
- Have active or history of autoimmune disease.
- Have active infections or significant heart disease.
- Have had recent major surgery or other cancer treatments.
- Have had a recent severe infection or are taking certain medications.
- Have had a recent live vaccine or severe allergic reactions.
- Have unresolved side effects from previous immunotherapy.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.
