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ATRA + PD-1 Inhibitor for Brain Tumor

Phase 2
Recruiting
Led By Stephen Bagley, MD MSCE
Research Sponsored by Stephen Bagley, MD, MSCE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 or older
Karnofsky performance status greater than or equal to 60
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 84 months
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat recurrent IDH-mutant glioma. The Sponsor-Investigator believes the proposed regimen will be safe and stimulate a robust anti-tumor immune response.

Who is the study for?
Adults with recurrent brain tumors (astrocytoma or oligodendroglioma) that have IDH mutations and have tried at least one chemo treatment can join. They must be able to perform daily activities, not pregnant, agree to contraception, and understand the study. Excluded are those with allergies to trial drugs, other serious illnesses, recent bevacizumab treatment, significant mass effect on the brain or active infections.Check my eligibility
What is being tested?
The trial tests a combination of All-Trans Retinoic Acid (ATRA) and PD-1 inhibitor Retifanlimab in patients with specific recurrent brain tumors. It aims to see if this mix is safe and boosts the immune system's ability to fight cancer.See study design
What are the potential side effects?
Possible side effects include allergic reactions to ATRA or Retifanlimab components, increased risk of infection due to immune suppression from treatments, lung issues like pneumonitis or interstitial lung disease, and potential autoimmune responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can care for myself but may not be able to do active work.
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I have a confirmed diagnosis of astrocytoma or oligodendroglioma that has worsened or returned after chemotherapy.
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I haven't used 5-ALA for surgery because it reacts with my ATRA treatment.
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I understand the study and agree to participate by signing the consent form.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~84 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 84 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective radiographic response (ORR)
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events as assessed by NCI CTCAE v 5.0
Overall survival
Progression Free Survival

Side effects data

From 2021 Phase 2 trial • 94 Patients • NCT03597295
23%
Asthenia
21%
Diarrhoea
18%
Fatigue
16%
Nausea
16%
Anaemia
15%
Vomiting
13%
Constipation
13%
Decreased appetite
12%
Pruritus
12%
Cough
12%
Dyspnoea
11%
Pyrexia
10%
Hypothyroidism
10%
Rectal haemorrhage
9%
Arthralgia
9%
Back pain
9%
Headache
9%
Weight decreased
7%
Urinary tract infection
7%
Proctalgia
7%
Aspartate aminotransferase increased
7%
Abdominal pain
6%
Insomnia
5%
Rash
5%
Hypokalaemia
5%
Cystitis
3%
Pelvic pain
3%
General physical health deterioration
2%
Intestinal obstruction
2%
Hypercalcaemia
2%
Haematuria
2%
Pleural effusion
2%
Inadequate analgesia
2%
Sepsis
2%
Pneumonia
1%
Acute kidney injury
1%
Adrenal insufficiency
1%
Ileus
1%
Anal abscess
1%
Respiratory failure
1%
Acute respiratory failure
1%
Purpura
1%
Cholecystitis acute
1%
Large intestinal obstruction
1%
Lyme disease
1%
Lymphangiosis carcinomatosa
1%
Herpes zoster
1%
Hepatitis
1%
Pelvic infection
1%
Peritonitis
1%
Blood bilirubin increased
1%
Body temperature increased
1%
Bone pain
1%
Cellulitis
1%
Cholangitis
1%
Cholecystitis
1%
Cognitive disorder
1%
Colonic fistula
1%
Coma hepatic
1%
Dehydration
1%
Device related infection
1%
Diffuse large B-cell lymphoma
1%
Fall
1%
Femur fracture
1%
Flank pain
1%
Gastric ulcer
1%
Gastroenteritis
1%
Hydronephrosis
1%
Immune-mediated enterocolitis
1%
Interstitial lung disease
1%
Mental status changes
1%
Pain
1%
Pancreatic carcinoma
1%
Proctitis haemorrhagic
1%
Pseudomonas infection
1%
Skin infection
1%
Stoma site infection
1%
Superior mesenteric artery syndrome
1%
Thrombosis
1%
Transitional cell carcinoma
1%
Tumour embolism
1%
Tumour pain
1%
Ureteric compression
1%
Urinary retention
1%
Venous thrombosis limb
1%
Pulmonary embolism
1%
Catheter site pain
1%
Pneumocystis jirovecii pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Retifanlimab 500 mg

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm D (surgical arm, ATRA + retifanlimab pre-operatively)Experimental Treatment2 Interventions
Subject in Arm D will receive the combination of ATRA 45mg/m2/day orally in two equally divided doses for 14 days pre-surgery plus a 500mg IV dose of retifanlimab 14 days prior to the date of surgery. Following surgery all patients will receive 28-day cycles of treatment, with ATRA 45mg/m2/day given orally in two equally divided doses on days 1-14 and retifanlimab 500mg IV on day 1.
Group II: Arm C (surgical arm, ATRA alone pre-operatively)Experimental Treatment2 Interventions
Subject in Arm C will receive ATRA 45mg/m2/day orally in two equally divided doses for 14 days pre-surgery, then undergo surgery. Following surgery all patients will receive 28-day cycles of treatment, with ATRA 45mg/m2/day given orally in two equally divided doses on days 1-14 and retifanlimab 500mg IV on day 1.
Group III: Arm B (failed only one prior alkylating chemotherapy)Experimental Treatment2 Interventions
Subject in Arm B are patients who have failed only one prior alkylating chemotherapy regimen and have gone at least 12 months since the last treatment. Subjects in Arm B will receive 28-day cycles of treatment, with ATRA 45mg/m2/day given orally in two equally divided doses on days 1 through 14 and retifanlimab 500mg IV on day 1.
Group IV: Arm A (failed prior TMZ + one other alkylating chemotherapy)Experimental Treatment2 Interventions
Subjects in Arm A are alkylator-refractory and at high risk for progression of disease, have failed temozolmide and another alkylating agent. Subjects in Arm A will receive 28-day cycles of treatment, with ATRA 45mg/m2/day given orally in two equally divided doses on days 1 through 14 and retifanlimab 500mg IV on day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Retifanlimab
2018
Completed Phase 2
~320
All-trans retinoic acid
2012
Completed Phase 3
~1050

Find a Location

Who is running the clinical trial?

University of PennsylvaniaOTHER
1,993 Previous Clinical Trials
42,875,508 Total Patients Enrolled
Stephen Bagley, MD, MSCELead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
362 Previous Clinical Trials
55,028 Total Patients Enrolled

Media Library

All-trans retinoic acid (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05345002 — Phase 2
Isocitrate Dehydrogenase Research Study Groups: Arm B (failed only one prior alkylating chemotherapy), Arm C (surgical arm, ATRA alone pre-operatively), Arm D (surgical arm, ATRA + retifanlimab pre-operatively), Arm A (failed prior TMZ + one other alkylating chemotherapy)
Isocitrate Dehydrogenase Clinical Trial 2023: All-trans retinoic acid Highlights & Side Effects. Trial Name: NCT05345002 — Phase 2
All-trans retinoic acid (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05345002 — Phase 2

Frequently Asked Questions

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

Are there still opportunities to participate in this research?

"The clinical trial in question, which can be found on clinicaltrials.gov, is not looking for any more patients at this moment in time. Although the study was originally posted on November 1st 2022 and edited as recently as October 6th of the same year, there are 403 other trials that are actively recruiting right now."

Answered by AI

Has Retifanlimab undergone FDA testing for safety and efficacy?

"While there is some data supporting Retifanlimab's safety, it received a score of 2 because this is only a Phase 2 trial and there is no evidence yet of the medication's efficacy."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~34 spots leftby Jun 2026