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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the cycle 1 start date until death due to any cause, assessed up to 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My kidney function, measured by creatinine levels, is within the normal range.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the cycle 1 start date until death due to any cause, assessed up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the cycle 1 start date until death due to any cause, assessed up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neoplasms
Incidence of adverse events
Secondary outcome measures
Duration of response
Evaluation of various immune biomarkers from tumor and blood biospecimens
Objective response rate
+3 moreSide effects data
From 2020 Phase 2 trial • 19 Patients • NCT0300684817%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Infections and infestations
6%
General disorders and administration site conditions
6%
Investigations
6%
Gastrointestinal disorders
6%
Cardiac disorders
6%
Immune system disorders
6%
Metabolism and nutrition disorders
6%
Nervous system disorders
6%
Endocrine disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Respiratory, thoracic and mediastinal disorders
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab
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
2018
Completed Phase 2
~2450
Radiation Therapy
2017
Completed Phase 3
~7250
Utomilumab
2018
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,608 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,980 Total Patients Enrolled
Aung NaingPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
533 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My brain tumor condition is currently stable.I have an autoimmune disease but it's not worsening with immune-stimulating treatments.I cannot tolerate or have not responded to standard treatments, or I refuse them.My partner can have children and we are not using two effective birth control methods.My doctor thinks radiation is unsafe for me due to my scleroderma, lupus, or similar condition.I've had radiation therapy in the last 3 months where the treatment areas might overlap.My kidney function, measured by creatinine levels, is within the normal range.I have recovered from recent cancer treatments, except for hair loss.I am not on seizure medication for brain cancer spread.I haven't had any cancer besides my current one in the last 3 years, except for treated skin cancer.I am not currently on any cancer treatment drugs.I have had an organ or stem-cell transplant.I have not received any live virus vaccines within the last 4 weeks.I have side effects from past treatments, but they are mild and not dangerous.I haven't had major cancer treatment or surgery in the last 4 weeks.I have not had a serious heart condition or stroke in the last 6 months.I am not on strong immune-suppressing drugs, except for low-dose or topical steroids.I do not have severe medical or psychiatric conditions that could worsen with this study.My cancer can be measured or evaluated using specific criteria.It has been more than 4 weeks since my last treatment.I am currently on medication for an infection.I am not on steroids for a brain tumor or its effects.I am fully active or can carry out light work.I have a brain tumor or my cancer has spread to my brain.My platelet count meets the required level for my type of cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C (PF-04518600, utomilumab, avelumab)
- Group 2: Arm A (utomilumab, avelumab)
- Group 3: Arm E (avelumab, PF-04518600, radiation therapy)
- Group 4: Arm D (avelumab, utomilumab, radiation therapy)
- Group 5: Arm B (PF-04518600, avelumab)
- Group 6: Arm F (avelumab, PF-04518600, radiation therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Avelumab been tested in any other clinical experiments?
"Currently, 114 clinical trials are underway which investigate the efficacy of Avelumab. Of these studies, 10 have entered Phase 3 with a multitude of sites across Houston and 36 other locations accruing patients for testing."
Answered by AI
How many participants is the research team recruiting for this investigation?
"As of September 22nd 2022, this trial has ceased to recruit patients. It first opened its call for applicants on August 2nd 2017. For those looking for similar studies, there are presently 5828 trials recruiting participants with neoplasms, malignant and 114 studies enrolling individuals into research involving Avelumab."
Answered by AI
Is this experimental research still taking on new participants?
"The clinical trial advertised on clinicaltrials.gov is not currently accepting candidates, however it was originally posted in August 2017 and last modified September 2022. Fortunately, there are 5942 other studies actively recruiting patients at this time."
Answered by AI
Has this experiment previously been conducted in any capacity?
"Research into avelumab started back in 2014, when it was trialed by EMD Serono Research & Development Institute. After completion of this study involving 204 participants, the drug recieved Phase 2 approval and is currently being tested in 114 clinical trials spanning over 1000 cities across 52 countries."
Answered by AI
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