Pembrolizumab in Association With the IMA950/Poly-ICLC for Relapsing Glioblastoma

NCT03665545 | Completed Phase 1

• 2 other identifiers: IMA950-106/CER 2018-00718MK3475-480
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Monocentric randomized phase I/II trial, including 24 patients diagnosed with relapsing glioblastoma (GBM) irrespective of MGMT and IDH gene status. Following diagnosis of relapsing glioblastoma by either brain CT scan or MRI, patients will be randomized in 2 arms:

1. 1.Arm 1: IMA950 mixed with Poly-ICLC administered subcutaneously
2. 2.Arm 2: Pembrolizumab 200mg q3w IV and IMA950 mixed with Poly-ICLC administered subcutaneously

Conditions

Glioblastoma Multiforme; Glioblastoma, Adult; Glioma of Brain; Glioblastoma Multiforme of Brain

Keywords

glioblastoma

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  To assess tolerability and safety of IMA950 adjuvanted with Poly-ICLC when given together with pembrolizumab, using CTCAE v.4.03

  From the time of treatment randomization through 30 days following cessation of treatment

Secondary Outcomes (3)

• Progression-free survival at 6, 9, 12 months

  through study completion, an average of 3 years

• Overall Survival

  through study completion, an average of 3 years

• Patient-reported Quality of life

  through study completion, an average of 3 years

Other Outcomes (2)

• Tumor Infiltrating Lymphocyte (TIL) density

  through study completion, an average of 3 years

• Vaccine-specific CD4 and CD8 cells

  through study completion, an average of 3 years

Study Arms (2)

IMA950/Poly-ICLC

ACTIVE COMPARATOR

IMA950 mixed with Poly-ICLC administered subcutaneously

Drug: IMA950/Poly-ICLC

IMA950/Poly-ICLC and pembrolizumab

EXPERIMENTAL

Pembrolizumab 200mg q3w IV and IMA950 mixed with Poly- ICLC administered subcutaneously

Drug: IMA950/Poly-ICLC; Drug: IMA950/Poly-ICLC and pembrolizumab

Interventions

IMA950/Poly-ICLC DRUG

IMA950 mixed with Poly-ICLC administered subcutaneously

IMA950/Poly-ICLC; IMA950/Poly-ICLC and pembrolizumab

IMA950/Poly-ICLC and pembrolizumab DRUG

IMA950 mixed with Poly-ICLC administered subcutaneously in combination with pembrolizumab

IMA950/Poly-ICLC and pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• The subject must be excluded from participating in the trial if the subject:
• Any other vaccination given within 2 weeks before first IMA950 vaccination.
• Diagnosis of immunodeficiency or active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a condition other than glioblastoma that requires systemic steroids (\> 10mg/day prednisone or equivalent) or immunosuppressive agents. Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Patients with evidence of history bleeding diathesis.
• Pregnant or breastfeeding patients, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
• Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
• Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
• Has a known history of active TB (Bacillus Tuberculosis)
• Hypersensitivity to pembrolizumab or any of its excipients.
• Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
• Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
• Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
• Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• Has known history of, or any evidence of active (non-infectious) pneumonitis that required(s) steroids.
• Has an active infection requiring systemic therapy.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University Hospitals of Geneva

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Nicolas Mach, Prof.

  University Hospital, Geneva

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2018
• First Posted: September 11, 2018
• Study Start: October 25, 2018
• Primary Completion: December 31, 2023
• Study Completion: April 24, 2024
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

CH (1)