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Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence
Phase 2 trial testing Pembrolizumab in Recurrent Glioblastoma in 41 participants. Completed in 16 February 2022.
| Lead sponsor | David Peereboom |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 41 |
| Start date | 19 March 2020 |
| Primary completion | 16 August 2021 |
| Estimated completion | 16 February 2022 |
| Sites | 1 location across United States |
David Peereboom — full company profile →
18 and older, any sex, with Recurrent Glioblastoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Assess clinical activity of Pembrolizumab and SurVaxM in patients with recurrent glioblastoma using PFS at 6 months (PFS-6)
| Group | Value | 95% CI |
|---|---|---|
| Arm A - Have Not Received Immunotherapy | 34.5 | 19.8 – 49.6 |
Safety and tolerability of Pembrolizumab and SurVaxM in patients with recurrent glioblastoma measured on ongoing basis with CTCAE v 5 grading as per NCI. Grade 1-2 and 3-5 events will be recorded and reported.
| Group | Value | 95% CI |
|---|---|---|
| Arm A - Have Not Received Immunotherapy | 481 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A - Have Not Received Immunotherapy | 107 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A - Have Not Received Immunotherapy | 43 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A - Have Not Received Immunotherapy | 6 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A - Have Not Received Immunotherapy | 31 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A - Have Not Received Immunotherapy | 508 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A - Have Not Received Immunotherapy | 6 |
| Group | Value | 95% CI |
|---|---|---|
| Arm A - Have Not Received Immunotherapy | 25 |
Time frame: Day 1 of treatment until 30 days after patient went off study, upto 19.7 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm A - Have Not Received … | Arm B - Have Failed Prior … |
|---|---|---|---|
| Edema cerebral | Nervous system disorders | — | — |
| Seizure | Nervous system disorders | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Cognitive disturbance | Nervous system disorders | — | — |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Muscle weakness left-sided | Nervous system disorders | — | — |
| Disease progression | General disorders | — | — |
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | — | — |
| Facial muscle weakness | Nervous system disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Nervous system disorders - Other, specify | Nervous system disorders | — | — |
| Thromboembolic event | Vascular disorders | — | — |
| Dysphagia | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Gait disturbance | General disorders | — | — |
| Platelet count decreased | Investigations | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | — | — |
| Dysphasia | Nervous system disorders | — | — |
| Muscle weakness right-sided | Nervous system disorders | — | — |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Cardiac arrest | Cardiac disorders | — | — |
| Sinus tachycardia | Cardiac disorders | — | — |
| Adrenal insufficiency | Endocrine disorders | — | — |
| Reaction | System | Arm A - Have Not Received … | Arm B - Have Failed Prior … |
|---|---|---|---|
| musculoskeletal | Musculoskeletal and connective tissue disorders | — | — |
| cognitive disturbance | Nervous system disorders | — | — |
| injection site reaction | Skin and subcutaneous tissue disorders | — | — |
| falls | General disorders | — | — |
| headache | Nervous system disorders | — | — |
| proteinuria | Renal and urinary disorders | — | — |
| fatigue | General disorders | — | — |
| paresthesia | Musculoskeletal and connective tissue disorders | — | — |
| mental or emotional change | Nervous system disorders | — | — |
| paresthesia | Nervous system disorders | — | — |
| seizure | Nervous system disorders | — | — |
| ast increased | Investigations | — | — |
| alt increased | Investigations | — | — |
| diarrhea | Gastrointestinal disorders | — | — |
| nausea | Gastrointestinal disorders | — | — |
| abnormal electrocytes | Investigations | — | — |
| death | Investigations | — | — |
| cerebral edema | Nervous system disorders | — | — |
| anc increased | Investigations | — | — |
| platelet decreased | Investigations | — | — |
| wbc increased | Investigations | — | — |
| thrombocytosis | Cardiac disorders | — | — |
| insomnia | General disorders | — | — |
| dysphagia | Gastrointestinal disorders | — | — |
| hyperglycemia | Investigations | — | — |
| wbc decreased | Investigations | — | — |
| hypothyroidism | Investigations | — | — |
| decreased appetite | General disorders | — | — |
| constipation | Gastrointestinal disorders | — | — |
| vomiting | Gastrointestinal disorders | — | — |
| aphasia | Nervous system disorders | — | — |
| dizziness | Nervous system disorders | — | — |
| memory loss | Nervous system disorders | — | — |
| tremor | Nervous system disorders | — | — |
| creatinine increased | Renal and urinary disorders | — | — |
| urinary frequency change | Renal and urinary disorders | — | — |
| pruritus | Skin and subcutaneous tissue disorders | — | — |
| rash | Skin and subcutaneous tissue disorders | — | — |
| anc decreased | Investigations | — | — |
| hypertension | Cardiac disorders | — | — |
Most-reported serious reactions: Edema cerebral, Seizure, Fall, Cognitive disturbance, Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify, Muscle weakness left-sided, Disease progression, Muscle weakness upper limb.
Data from ClinicalTrials.gov NCT04013672 adverse events section.
The main purpose of this study is to assess the clinical activity of Pembrolizumab and SurVaxM in participants with recurrent glioblastoma.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing