18 and older, any sex, with Glioblastoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pembrolizumab Maximum Tolerated Dose (MTD) [Cohort A Safety Lead-In]Primary· one cycle/42 days
The MTD of pembrolizumab in combination with bevacizumab 10 mg/kg intravenously (IV) on days 1, 15 and 29 of each 42 day cycle is determined by the number of participants who experience a dose limiting toxicity (DLT) at the various regimens of dosing frequency of pembrolizumab 200 mg IV administered under evaluation. See subsequent primary outcome measure for the DLT definition. The MTD is defined as the pembrolizumab dose frequency regimen at which fewer than one-third of participants experience a DLT. If de-escalation does not occur per design, then the starting dose is the Recommended Phase
Group
Value
95% CI
Cohort A Safety Lead-In: Pembrolizumab (DL 0) + Bevacizumab
200
Pembrolizumab Dose Limiting Toxicity (DLT) [Cohort A Safety Lead-In]Primary· The evaluation for MTD occurred continuously through one cycle of treatment (42 days).
A DLT is defined as an adverse event (AE) that (a) is \>= grade 3 and related to the pembrolizumab with an attribution of possible, probably or definite, and (b) occurs during and/or begins during the first 42 days of study treatment, and (c) does not meet any of the following exception criteria: grade 3 immune-related AE that downgrades to \<= grade 2 within 5 days, or \<= grade 1/baseline within 14 days of onset; grade 3 asymptomatic endocrinopathy; grade 3 inflammatory reaction attribution to anti-tumor response; grade 3 pneumonitis, neurologic event, or uveitis that downgrades to \<=grade
Group
Value
95% CI
Cohort A Safety Lead-In: Pembrolizumab (DL 0) + Bevacizumab
0
6-Month Progression-Free Survival (PFS6)Primary· Disease was assessed radiographically for response every cycle on treatment. Treatment duration in cycles (cycle=42 days) was a mean (SD) of 4.5 (4.4) for Cohort A and 2.5 (2.7) for Cohort B. Assessment at week 72/cycle 12 pertains to the 6-month PFS.
PFS6 is the proportion of patients remaining alive and progression-free at 6-months from study entry.
Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria. PD is a \>25% increase in sum of perpendicular diameters of all measurable enhancing lesions, significant increase of non-enhancing lesions, any new lesions, clear clinical deterioration, failure to return for evaluation due to death or deteriorating condition.
Group
Value
95% CI
Cohort A: Pembrolizumab + Bevacizumab
0.26
0.146 – 0.403
Cohort B: Pembrolizumab
0.067
0.009 – 0.221
Progression-Free Survival (PFS)Secondary· Disease was assessed radiographically for response every cycle on treatment and every 6 weeks long-term. Median PFS follow-up (months) was 25 for Cohort A and 26 for Cohort B.
PFS based on Kaplan-Meier is defined as the time from study entry to the earliest documentation of disease progression (PD) or death. Participants alive without evidence of PD were censored at the date of last disease assessment. Per Response Assessment in Neuro-Oncology (RANO) criteria, PD is a \>25% increase in sum of perpendicular diameters of all measurable enhancing lesions, significant increase of non-enhancing lesions, any new lesions, clear clinical deterioration, failure to return for evaluation due to death or deteriorating condition.
Group
Value
95% CI
Cohort A: Pembrolizumab + Bevacizumab
4.1
2.8 – 5.5
Cohort B: Pembrolizumab
1.4
1.4 – 2.7
Overall Survival (OS)Secondary· Participants were followed long-term for survival every 3 months from the end of treatment until death or lost to follow-up. Median survival follow-up was 25 months for each cohort.
OS based on Kaplan-Meier is defined as the time from study entry to death or date last known alive.
Group
Value
95% CI
Cohort A: Pembrolizumab + Bevacizumab
8.8
7.7 – 14.2
Cohort B: Pembrolizumab
10.3
8.5 – 12.5
Overall Radiographic Response (ORR)Secondary· Disease was assessed radiographically for response every cycle on treatment. Treatment duration in cycles (each cycle=42 days) was a mean (SD) of 4.5 (4.4) for Cohort A and 2.5 (2.7) for Cohort B.
ORR was established based on Response Assessment in Neuro-Oncology (RANO) criteria. RANO criteria has 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown. CR: disappearance of all enhancing lesions, stable or improved non-enhancing lesions, and stable or improved clinically. PR: \>= 50% decrease in sum of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, stable or improved non-enhancing lesions, and stable or improved clinically. PD: \>25% increase in sum of perpend
Group
Value
95% CI
Cohort A: Pembrolizumab + Bevacizumab
0.20
0.11 – 0.32
Cohort B: Pembrolizumab
0.0
0.0 – 0.095
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events (AEs) were assessed each cycle throughout treatment from time of first dose and up to day 30 post-treatment for unresolved AEs and up to day 90 for serious adverse events. AEs were evaluated over treatment which was a maximum duration of 16 cycles (approximates 22 months)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort A: Pembrolizumab + Bevacizumab
Serious: 22/50 (44%)
Deaths: 3/50
Cohort B: Pembrolizumab
Serious: 10/30 (33%)
Deaths: 1/30
Serious adverse events (38 terms)
Reaction
System
Cohort A: Pembrolizumab + …
Cohort B: Pembrolizumab
Headache
Nervous system disorders
—
—
Surgical and medical procedures - Other
Surgical and medical procedures
—
—
Intracranial hemorrhage
Nervous system disorders
—
—
Diarrhea
Gastrointestinal disorders
—
—
Gait disturbance
General disorders
—
—
Hypertension
Vascular disorders
—
—
Nervous system disorders - Other
Nervous system disorders
—
—
Seizure
Nervous system disorders
—
—
Thromboembolic event
Vascular disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Alanine aminotransferase increased
Investigations
—
—
Anemia
Blood and lymphatic system disorders
—
—
Confusion
Psychiatric disorders
—
—
Death NOS
General disorders
—
—
Dizziness
Nervous system disorders
—
—
Dysphasia
Nervous system disorders
—
—
Edema cerebral
Nervous system disorders
—
—
Encephalopathy
Nervous system disorders
—
—
Fatigue
General disorders
—
—
Fever
General disorders
—
—
Gastric ulcer
Gastrointestinal disorders
—
—
Hemorrhoids
Gastrointestinal disorders
—
—
Infections and infestations - Other
Infections and infestations
—
—
Infusion related reaction
General disorders
—
—
Lethargy
Nervous system disorders
—
—
Other adverse events (184 terms — click to expand)
In this research study, the investigators are looking to determine the effectiveness of Pembrolizumab (MK-3475) when given with bevacizumab or when given alone for the treatment of recurrent glioblastoma multiforme (GBM). This study will also test the safety and tolerability of Pembrolizumab (MK-3475) when given alone or with bevacizumab.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
· not yet recruiting
NCT07275216 — Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Stand
· Phase 2
· not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan
· Phase 1, PHASE2
· recruiting
NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors
· Phase 1
· not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
Other recruiting trials for Glioblastoma
Currently open trials in the same condition.
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· EARLY_PHASE1
· recruiting
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· Phase 2
· recruiting
NCT07480941 — Dual-Targeting CAR-NK Cells for Recurrent/Progressive Glioblastoma and High-Grade Glioma
· Phase 1
· recruiting
NCT07448480 — Comprehensive Analysis of Chemotherapy and Targeted Therapy Outcomes in Recurrent Malignant Gliomas
· active not recruiting
NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors
· Phase 1, PHASE2
· recruiting
Other Dana-Farber Cancer Institute trials
Trials by the same sponsor.
NCT07519200 — Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention
· NA
· not yet recruiting
NCT07499999 — Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk fo
· Phase 2
· not yet recruiting
NCT05825469 — Development and Testing of Nutritional Algorithms (NACHO)
· NA
· not yet recruiting
NCT07516353 — my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults
· NA
· not yet recruiting
NCT07513324 — Risk-adapted Therapy in HPV-positive Oropharyngeal Cancer Using Circulating Tumor (ct) HPV DNA Profiling (ReACT 2.0)
· Phase 2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dana-Farber Cancer Institute
Last refreshed: 22 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02337491.