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Monoclonal Antibodies

Anti-OX40 Agonist Monoclonal Antibody PF-04518600 for Acute Myelogenous Leukemia

Phase 1 & 2
Waitlist Available
Led By Naval G Daver
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
Prior therapy with hydroxyurea, chemotherapy, biological or targeted therapy (e.g. FLT3 inhibitors, other kinase inhibitors), or hematopoietic growth factors is permitted.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat patients with acute myeloid leukemia that has come back or does not respond to treatment. The drugs will be given to see if they help the body's immune system attack the cancer, and if they stop the growth of tumor cells.

Eligible Conditions
  • Acute Myelogenous Leukemia
  • Acute Myeloid Leukemia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You can participate in the study if you have received treatment with certain medications in the past, including hydroxyurea, chemotherapy, biological or targeted therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With a Response
Secondary outcome measures
Overall Survival

Side effects data

From 2022 Phase 1 & 2 trial • 50 Patients • NCT03390296
23%
Febrile Neutropenia
23%
Lung infection
15%
Alanine aminotransferase increased
8%
Hematuria
8%
Immune System Disorders
8%
Syncope
8%
Nausea
8%
Platelet count decreased
8%
Pericardial effusion
8%
Blood bilirubin increased
8%
Blood and lymphatic system disorders - Other, specify
8%
Pericarditis
8%
Constipation
8%
Acute kidney injury
8%
Fatigue
8%
Intracranial hemorrhage
8%
Lower gastrointestinal hemorrhage
8%
Soft tissue infection
8%
Urinary retention
8%
Urinary tract infection
8%
Anemia
8%
Aspartate aminotransferase
8%
Infections and infestations - Other, specify
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm D (Azacitidine, Venetoclax, Avelumab)
Arm E (Azacitidine, Avelumab, Anti-OX40 Antibody PF-04518600)
Arm C (Azacitidine, GO, Avelumab)
Arm B (Azacitidine, Venetoclax, GO)
Arm A (Anti-OX40 Antibody PF-04518600)
Arm F (GO, Glasdegib)

Trial Design

6Treatment groups
Experimental Treatment
Group I: Arm F (GO, glasdegib)Experimental Treatment3 Interventions
Patients receive GO IV over 2 hours on days 1, 4, and 7, and glasdegib PO on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm E (azacitidine, avelumab, anti-OX40 antibody PF-04518600)Experimental Treatment3 Interventions
Patients receive azacitidine and avelumab as in Arm C and anti-OX40 antibody PF-04518600 as in Arm A. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group III: Arm D (azacitidine, venetoclax, avelumab)Experimental Treatment3 Interventions
Patients receive azacitidine and venetoclax as in Arm A and avelumab as in Arm C. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group IV: Arm C (azacitidine, GO, avelumab)Experimental Treatment3 Interventions
Patients receive azacitidine and GO as in Arm B. Patients also receive avelumab IV over 60 minutes on days 1 and 14. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group V: Arm B (azacitidine, venetoclax, GO)Experimental Treatment3 Interventions
Patients receive azacitidine IV over 10-40 minutes or via injection SC on days 1-7 or 1-5 and 8-9. Patients also receive venetoclax PO on days 1-28 and GO IV over 2 hours on day 8. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group VI: Arm A (anti-OX40 antibody PF-04518600)Experimental Treatment1 Intervention
Patients receive anti-OX40 antibody PF-04518600 IV over 60 minutes on days 1 and 14. 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
Glasdegib
2015
Completed Phase 3
~100
Anti-OX40 Agonist Monoclonal Antibody PF-04518600
2017
Completed Phase 2
~50
Avelumab
2018
Completed Phase 2
~2450
Glasdegib Maleate
2017
Completed Phase 2
~50
Venetoclax
2019
Completed Phase 3
~1990
Azacitidine
2012
Completed Phase 3
~1440
Gemtuzumab Ozogamicin
2006
Completed Phase 4
~440

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,399 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,596 Total Patients Enrolled
Naval G DaverPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
135 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary benefits of Anti-OX40 Agonist Monoclonal Antibody PF-04518600?

"Anti-OX40 Agonist Monoclonal Antibody PF-04518600 is a medication that oncologists often prescribe to treat malignant neoplasms. This drug can also help patients with comorbidity, neutropenia and/or thrombocytopenia, and anemia."

Answered by AI

Are there any other drugs that have been tested in a similar way to Anti-OX40 Agonist Monoclonal Antibody PF-04518600?

"There are a total of 493 ongoing clinical trials for Anti-OX40 Agonist Monoclonal Antibody PF-04518600, with 69 of those in Phase 3. While some of the Alberta-based trials for this medication are close to being full, there are 15399 other locations across the world running clinical trials."

Answered by AI

How many people will be participating in this study at its peak?

"Unfortunately, this particular trial is no longer looking for patients. Although, it was last updated on September 22nd, 2022. There are currently 1522 trials actively recruiting patients with leukemia and 493 trials for Anti-OX40 Agonist Monoclonal Antibody PF-04518600 that are admitting patients."

Answered by AI

Are we still enrolling participants for this clinical trial?

"Unfortunately, this particular trial is not currently looking for new participants. Although the study was originally posted on December 27th, 2017, recruitment has since closed. However, there are over 2 thousand other trials that are still recruiting patients right now."

Answered by AI
~7 spots leftby Mar 2025