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Monoclonal Antibodies

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

Phase 1 & 2

Waitlist Available

Led By Aung Naing

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Serum creatinine =< 2 x upper limit of normal (ULN) or estimated creatinine clearance >= 30 ml/min as calculated using the Cockcroft-Gault formula.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Must not have

Clinically stable with respect to the CNS tumor at the time of study entry

Not receiving anti-convulsive medications (that were started for brain metastases).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from cycle 1 start date until the earliest date of disease progression, assessed up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects of avelumab in combination with utomilumab, anti-OX40 antibody PF-04518600, and radiation therapy in treating patients with advanced malignancies.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects include reactions related to the immune system such as inflammation in various organs, infusion-related reactions which can occur during treatment administration, fatigue, possible changes in blood counts leading to increased infection risk or bleeding tendencies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function, measured by creatinine levels, is within the normal range.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My brain tumor condition is currently stable.

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I am not on seizure medication for brain cancer spread.

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I haven't had any cancer besides my current one in the last 3 years, except for treated skin cancer.

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I am not currently on any cancer treatment drugs.

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I have had an organ or stem-cell transplant.

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I have not received any live virus vaccines within the last 4 weeks.

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I am currently on medication for an infection.

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I am not on steroids for a brain tumor or its effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from cycle 1 start date until the earliest date of disease progression, assessed up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from cycle 1 start date until the earliest date of disease progression, assessed up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and from cycle 1 start date until the earliest date of disease progression, assessed up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Secondary study objectives

Duration of response

Objective response rate

Progression-free survival

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848

17%

Musculoskeletal and connective tissue disorders

11%

Injury, poisoning and procedural complications

General disorders and administration site conditions

Metabolism and nutrition disorders

Nervous system disorders

Endocrine disorders

Investigations

Cardiac disorders

Gastrointestinal disorders

Infections and infestations

Immune system disorders

Blood and lymphatic system disorders

Neoplasms benign, malignant and unspecified

Respiratory, thoracic and mediastinal disorders

Renal and urinary disorders

Skin and subcutaneous tissue disorders

100%

80%

60%

40%

20%

Study treatment Arm

Avelumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Avelumab

2017

Completed Phase 2

~2440

Radiation Therapy

2017

Completed Phase 3

~7250