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Retifanlimab and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas
Phase 2 trial testing Epacadostat in Glioma in 51 participants. Completed in 31 October 2025.
| Lead sponsor | Washington University School of Medicine |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 51 |
| Start date | 20 April 2020 |
| Primary completion | 26 July 2024 |
| Estimated completion | 31 October 2025 |
| Sites | 4 locations across United States |
Washington University School of Medicine
18 and older, any sex, with Glioma or Glioblastoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall survival is defined as the time interval from date of treatment start to date of a documented death event (death due to any cause) or date of censoring. If a patient has not had an event, OS will be censored at the date of last follow up.
| Group | Value | 95% CI |
|---|---|---|
| Regimen A: Retifanlimab+RT+bevacizumab | 67 | 50 – 82 |
| Regimen B: Retifanlimab+RT+bevacizumab+epacadostat | 67 | 51 – 89 |
Overall survival is defined as the time interval from date of treatment start to date of a documented death event (death due to any cause) or date of censoring. If a patient has not had an event, OS will be censored at the date of last follow up.
| Group | Value | 95% CI |
|---|---|---|
| Regimen A: Retifanlimab+RT+bevacizumab | 50 | 34 – 75 |
| Regimen B: Retifanlimab+RT+bevacizumab+epacadostat | 38 | 23 – 63 |
Overall survival is defined as the time interval from date of treatment start to date of a documented death event (death due to any cause) or date of censoring. If a patient has not had an event, OS will be censored at the date of last follow up.
| Group | Value | 95% CI |
|---|---|---|
| Regimen A: Retifanlimab+RT+bevacizumab | 11.53 | 9.79 – 17.97 |
| Regimen B: Retifanlimab+RT+bevacizumab+epacadostat | 10.55 | 9.23 – 13.83 |
* There are 9 domains (gait, strength, ataxia, sensation, visual fields, facial strength, language, level of consciousness, and behavior). * Each domain is subdivided into 3 or 4 levels of function with scores based on discrete quantifiable measures. Each domain is scored from 0 to 3 points based on the severity of neurological deficit. A score of 0 indicates normal neurologic function, a score of 1 indicates mild impairment, 2 indicates severe impairment, and the highest score of 3 indicates the most severe level of deficit (incomplete hemianopsia) for that domain. Levels of function are dist
| Group | Value | 95% CI |
|---|---|---|
| Regimen A: Retifanlimab+RT+bevacizumab | 1.875 | ± 2.071 |
| Regimen B: Retifanlimab+RT+bevacizumab+epacadostat | 2.12 | ± 2.333 |
| Group | Value | 95% CI |
|---|---|---|
| Regimen A: Retifanlimab+RT+bevacizumab | 2.952 | ± 2.906 |
| Regimen B: Retifanlimab+RT+bevacizumab+epacadostat | 3.273 | ± 2.865 |
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting
| Group | Value | 95% CI |
|---|---|---|
| Regimen A: Retifanlimab+RT+bevacizumab | 1 | |
| Regimen B: Retifanlimab+RT+bevacizumab+epacadostat | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Regimen A: Retifanlimab+RT+bevacizumab | 2 | |
| Regimen B: Retifanlimab+RT+bevacizumab+epacadostat | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Regimen A: Retifanlimab+RT+bevacizumab | 1 | |
| Regimen B: Retifanlimab+RT+bevacizumab+epacadostat | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Regimen A: Retifanlimab+RT+bevacizumab | 2 | |
| Regimen B: Retifanlimab+RT+bevacizumab+epacadostat | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Regimen A: Retifanlimab+RT+bevacizumab | 0 | |
| Regimen B: Retifanlimab+RT+bevacizumab+epacadostat | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Regimen A: Retifanlimab+RT+bevacizumab | 4 | |
| Regimen B: Retifanlimab+RT+bevacizumab+epacadostat | 5 |
| Group | Value | 95% CI |
|---|---|---|
| Regimen A: Retifanlimab+RT+bevacizumab | 0 | |
| Regimen B: Retifanlimab+RT+bevacizumab+epacadostat | 3 |
* Duration of time from start of treatment to radiographic progression or death due to any cause, whichever occurs first * Radiographic progression will be assessed using the RECIST 1.1. If the disease recurrence/progression assessment involves more than one date, the earliest date will be used as the event date. A patient will be censored at the date of the last radiographic disease assessment indicating a lack of disease progression, if any of the following occurs before documented disease progression: alive and lack evidence of progression at the end of study or at the time of analysis data
| Group | Value | 95% CI |
|---|---|---|
| Regimen A: Retifanlimab+RT+bevacizumab | 42 | 26 – 67 |
| Regimen B: Retifanlimab+RT+bevacizumab+epacadostat | 21 | 10 – 45 |
* Duration of time from start of treatment to radiographic progression or death due to any cause, whichever occurs first * Radiographic progression will be assessed using the RECIST 1.1. If the disease recurrence/progression assessment involves more than one date, the earliest date will be used as the event date. A patient will be censored at the date of the last radiographic disease assessment indicating a lack of disease progression, if any of the following occurs before documented disease progression: alive and lack evidence of progression at the end of study or at the time of analysis data
| Group | Value | 95% CI |
|---|---|---|
| Regimen A: Retifanlimab+RT+bevacizumab | 25 | 13 – 50 |
| Regimen B: Retifanlimab+RT+bevacizumab+epacadostat | 4 | 1 – 28 |
* Duration of time from start of treatment to radiographic progression or death due to any cause, whichever occurs first * Radiographic progression will be assessed using the RECIST 1.1. If the disease recurrence/progression assessment involves more than one date, the earliest date will be used as the event date. A patient will be censored at the date of the last radiographic disease assessment indicating a lack of disease progression, if any of the following occurs before documented disease progression: alive and lack evidence of progression at the end of study or at the time of analysis data
| Group | Value | 95% CI |
|---|---|---|
| Regimen A: Retifanlimab+RT+bevacizumab | 6.98 | 5.55 – 11.04 |
| Regimen B: Retifanlimab+RT+bevacizumab+epacadostat | 7.20 | 5.78 – 8.61 |
Time frame: Adverse events were collected from time of consent through 90 days following the last date of treatment. All-cause mortality was collected from start of treatment through completion of follow-up (up to 4 years).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Regimen A: Retifanlimab+RT… | Regimen B: Retifanlimab+RT… |
|---|---|---|---|
| Seizure | Nervous system disorders | — | — |
| Confusion | Psychiatric disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — |
| Edema cerebral | Nervous system disorders | — | — |
| Encephalopathy | Nervous system disorders | — | — |
| Intracranial hemorrhage | Nervous system disorders | — | — |
| Stroke | Nervous system disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Colitis | Gastrointestinal disorders | — | — |
| Dysphagia | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Death NOS | General disorders | — | — |
| Fatigue | General disorders | — | — |
| Gait disturbance | General disorders | — | — |
| Ehrlichhiosis | Infections and infestations | — | — |
| Lung infection | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Wound infection | Infections and infestations | — | — |
| Hip fracture | Injury, poisoning and procedural complications | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| BUN increased | Investigations | — | — |
| Platelet count decreased | Investigations | — | — |
| Weight loss | Investigations | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Reaction | System | Regimen A: Retifanlimab+RT… | Regimen B: Retifanlimab+RT… |
|---|---|---|---|
| Hypertension | Vascular disorders | — | — |
| Fatigue | General disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Proteinuria | Renal and urinary disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| Platelet count decreased | Investigations | — | — |
| Weight loss | Investigations | — | — |
| White blood cell decreased | Investigations | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Creatinine increased | Investigations | — | — |
| Hyperkalemia | Metabolism and nutrition disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Confusion | Psychiatric disorders | — | — |
| Hypothyroidism | Endocrine disorders | — | — |
| Fever | General disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Thyroid stimulating hormone increased | Investigations | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Weight gain | Investigations | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Dysphasia | Nervous system disorders | — | — |
| Muscle weakness left-sided | Nervous system disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Cognitive disturbance | Nervous system disorders | — | — |
| Seizure | Nervous system disorders | — | — |
| Hematuria | Renal and urinary disorders | — | — |
Most-reported serious reactions: Seizure, Confusion, Diarrhea, Generalized muscle weakness, Edema cerebral, Encephalopathy, Intracranial hemorrhage, Stroke.
Data from ClinicalTrials.gov NCT03532295 adverse events section.
In this study, the investigators propose to combine retifanlimab with radiation therapy (RT) and bevacizumab with or without epacadostat in the treatment of recurrent glioblastoma (GBM). The investigators hypothesize that this combination provides a powerful synergy between RT and immune modulators to produce more robust anti-tumor immune response, induce tumor regression and improve overall survival.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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