Avelumab + Utomilumab + Anti-OX40 + Radiation for Advanced Cancers

Recruiting in Palo Alto (17 mi)

Overseen byAung Naing, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase I/II trial studies the side effects of avelumab when given in different combinations with utomilumab, anti-OX40 antibody PF-04518600, and radiation therapy in treating patients with malignancies that have spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as avelumab, utomilumab, and anti-OX40 antibody PF-04518600, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high-energy rays to kill tumor cells and shrink tumors. It is not yet known how well avelumab works in combination with these other anti-cancer therapies in patients with advanced malignancies.

Research Team

Aung Naing, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients with advanced malignancies, specifically prostate cancer or solid tumors that have spread. Participants must have measurable disease, be in good physical condition (ECOG 0-1), and meet specific blood count and organ function criteria. Women of childbearing potential must test negative for pregnancy and agree to use contraception; men also need to commit to using effective birth control.

Inclusion Criteria

I am not pregnant and agree to use birth control during and 90 days after treatment.

I have multiple tumors that can be biopsied and measured for treatment response.

I cannot tolerate or have not responded to standard treatments, or I refuse them.

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Exclusion Criteria

My brain tumor condition is currently stable.

Treatment with an investigational anti-cancer study drug within 4 weeks prior to study drug administration date.

I have an autoimmune disease but it's not worsening with immune-stimulating treatments.

See 23 more

Treatment Details

Interventions

Anti-OX40 Antibody PF-04518600 (Monoclonal Antibodies)
Avelumab (Monoclonal Antibodies)
Radiation Therapy (Radiation)
Utomilumab (Monoclonal Antibodies)

Trial OverviewThe study is testing the effectiveness of avelumab combined with utomilumab, anti-OX40 antibody PF-04518600, and radiation therapy on advanced cancers. It's a phase I/II trial aiming to see how well these treatments work together in stopping cancer growth by aiding the immune system.

Participant Groups

6Treatment groups

Experimental Treatment

Group I: Arm F (avelumab, PF-04518600, radiation therapy)Experimental Treatment4 Interventions

DISCONTINUED AS OF AMENDMENT 9 (02/11/2020) Patients undergo radiation therapy on days -14 to -1. Patients receive avelumab IV over 60 minutes on days 1 and 15 beginning day 15 of cycle 1, utomilumab IV over 60 minutes on day 1, and anti-OX40 agonist monoclonal antibody PF-04518600 IV on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm E (avelumab, PF-04518600, radiation therapy)Experimental Treatment3 Interventions

DISCONTINUED AS OF AMENDMENT 9 (02/11/2020) Patients undergo radiation therapy on days -14 to -1. Patients receive avelumab IV over 60 minutes on days 1 and 15 beginning day 15 of cycle 1 and anti-OX40 agonist monoclonal antibody PF-04518600 IV over 60 minutes on days 1 and 15, and. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group III: Arm D (avelumab, utomilumab, radiation therapy)Experimental Treatment3 Interventions

Patients undergo radiation therapy on days -5 to -1. Patients receive avelumab IV over 60 minutes on days 1 and 15 of beginning day 15 of cycle 1 and utomilumab IV over 60 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group IV: Arm C (PF-04518600, utomilumab, avelumab)Experimental Treatment3 Interventions

Patients receive anti-OX40 agonist monoclonal antibody PF-04518600 IV over 60 minutes on days 1 and 15 of each cycle, utomilumab over 60 minutes on day 1, and avelumab IV over 60 minutes on days 1 and 15 beginning day 15 of cycle 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group V: Arm B (PF-04518600, avelumab)Experimental Treatment2 Interventions

Patients receive anti-OX40 agonist monoclonal antibody PF-04518600 IV over 60 minutes on days 1 and 15 of each cycle and avelumab IV over 60 minutes on days 1 and 15 beginning day 15 of cycle 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group VI: Arm A (utomilumab, avelumab)Experimental Treatment2 Interventions

Patients receive utomilumab IV over 60 minutes on day 1 of each cycle and avelumab IV over 60 minutes on days 1 and 15 beginning day 15 of cycle 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.