NSCLC
Conditions
Keywords
PD-1, PD-L1, Programmed Cell Death 1, Chemotherapy, Pemetrexed, Carboplatin, Pembrolizumab, Immunotherapy, IO102, Keytruda
Brief summary
The purpose of this study is to determine if IO102 combined with pembrolizumab with or without chemotherapy is safe tolerable and effective in the treatment of Non-small Cell Lung Carcinoma (NSCLC). The hypothesis is that IO102 will improve the objective response rate (ORR) in patients with metastatic NSCLC.
Interventions
BIOLOGICALIO102
test immunotherapy
BIOLOGICALpembrolizumab (Keytruda)
anti-PD-1 immunotherapy
DRUGCarboplatin (Carboplatin Kabi)
chemotherapy
DRUGPemetrexed (Pemetrexed Alvogen)
chemotherapy
Sponsors
Merck Sharp & Dohme LLC
IO Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed metastatic NSCLC or non squamous NSCLC * Have biomarker-positive solid tumor * Male participants of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study medication through 120 days after the last dose of study medication * Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication * The participant must provide written informed consent * Have measurable disease per RECIST 1.1 * Have provided a blood sample and archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated * Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 * Adequate organ function
Exclusion criteria
* Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE) * 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 * Radiotherapy within 2 weeks of start of trial treatment * Vaccination with a live vaccine within 30 days prior to the first dose of trial treatment.Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist®) are live attenuated vaccines and are not allowed. * Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment. * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of trial treatment. * Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. * Has known active CNS metastases and/or carcinomatous meningitis. * Has severe hypersensitivity (≥Grade 3) to IO102, pembrolizumab, carboplatin, pemetrexed and/or any of its excipients. * Has an active autoimmune disease that has required systemic treatment in past 2 years. * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. * Has an active infection requiring systemic therapy. * Has a known history of human immunodeficiency virus (HIV) infection. * Known active Hepatitis B or Hepatitis C * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial. * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1 (safety run-in) | One cycle i.e. 3 weeks | Dose Limiting Toxicity graded per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 |
| Phase 2 (efficacy) | From date of randomization until date of death from any cause, withdrawal of consent or loss to follow up whichever came first, assessed for up to 35 cycles (2 years) | Objective Response Rate (ORR) evaluated by RECIST 1.1 and defined as the rate of complete response (CR) + partial response (PR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | From date of randomization until date of death from any cause, withdrawal of consent or loss to follow up whichever came first, assessed for up to 35 cycles (2 years) | by baseline PD-L1 expression |
Countries
Germany, Netherlands, Spain, United Kingdom
Outcome results
None listed