IO102 With Pembrolizumab, With or Without Chemotherapy, as First-line Treatment of Metastatic NSCLC
NCT ID: NCT03562871
Last Updated: 2022-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
109 participants
INTERVENTIONAL
2018-08-22
2022-04-12
Brief Summary
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The hypothesis is that IO102 will improve the objective response rate (ORR) in patients with metastatic NSCLC.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A1
Drug: IO102 100µg administered subcutaneously (SC) on Day 1 of each 3 week cycle PLUS Drug: pembrolizumab (Keytruda) 200 mg intravenous (IV) infusion on Day 1 of each 3 week cycle
IO102
test immunotherapy
pembrolizumab (Keytruda)
anti-PD-1 immunotherapy
Cohort A2
Drug: pembrolizumab (Keytruda) 200 mg IV infusion on Day 1 of each 3 week cycle
pembrolizumab (Keytruda)
anti-PD-1 immunotherapy
Cohort B1
Drug: IO102 100µg SC on Day 1 of each 3 week cycle PLUS Drug: pembrolizumab (Keytruda) 200 mg IV on Day 1 of each 3 week cycle PLUS Drug: carboplatin (Carboplatin Kabi) at a target AUC of 5 mg/mL IV infusion on Day 1 of each 3 week cycle for a max of 4 administrations PLUS Drug: pemetrexed (Pemetrexed Alvogen) at 500 mg/m2 IV infusion on Day 1 of each 3 week cycle
IO102
test immunotherapy
pembrolizumab (Keytruda)
anti-PD-1 immunotherapy
Carboplatin (Carboplatin Kabi)
chemotherapy
Pemetrexed (Pemetrexed Alvogen)
chemotherapy
Cohort B2
Drug: pembrolizumab (Keytruda) 200 mg IV on Day 1 of each 3 week cycle PLUS Drug: carboplatin (Carboplatin Kabi) at a target AUC of 5 mg/mL IV infusion on Day 1 of each 3 week cycle for a max of 4 administrations PLUS Drug: pemetrexed (Pemetrexed Alvogen) at 500 mg/m2 IV infusion on Day 1 of each 3 week cycle
pembrolizumab (Keytruda)
anti-PD-1 immunotherapy
Carboplatin (Carboplatin Kabi)
chemotherapy
Pemetrexed (Pemetrexed Alvogen)
chemotherapy
Interventions
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IO102
test immunotherapy
pembrolizumab (Keytruda)
anti-PD-1 immunotherapy
Carboplatin (Carboplatin Kabi)
chemotherapy
Pemetrexed (Pemetrexed Alvogen)
chemotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
IO Biotech
INDUSTRY
Responsible Party
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Principal Investigators
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James Spicer, MD Prof
Role: PRINCIPAL_INVESTIGATOR
Guy's Hospital
Locations
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Thoraxklinik Heidelberg gGmbH
Heidelberg, Community of Heidelberg, Germany
PIUS Hospital Oldenburg
Oldenburg, , Germany
Stichting Het Nederlands Kanker Instituut
Amsterdam, Community of Amsterdam, Netherlands
Servicio de Oncología-El médico del Virgen de la Victoria
Málaga, Andalusia, Spain
Insituto Oncologico Dr Rosell. Hospital Universitario Quiron Dexeus
Barcelona, Catalonia, Spain
Hospital Universitario de Vall d'Hebron
Barcelona, Catalonia, Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Catalonia, Spain
Hospital Clinico Universitario de València
Valencia, Horta de València, Spain
Hospital Universitario 12 Octubre
Madrid, Madrid, Spain
Hospital Universitario HM Sanchinarro
Madrid, Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain
Hospital Puerta del Hierro Majadahonda
Madrid, Madrid, Spain
Guy's Hospital
London, , United Kingdom
Countries
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References
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Langer CJ, Gadgeel SM, Borghaei H, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Ge Y, Raftopoulos H, Gandhi L; KEYNOTE-021 investigators. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016 Nov;17(11):1497-1508. doi: 10.1016/S1470-2045(16)30498-3. Epub 2016 Oct 10.
Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR; KEYNOTE-024 Investigators. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2016 Nov 10;375(19):1823-1833. doi: 10.1056/NEJMoa1606774. Epub 2016 Oct 8.
Iversen TZ, Engell-Noerregaard L, Ellebaek E, Andersen R, Larsen SK, Bjoern J, Zeyher C, Gouttefangeas C, Thomsen BM, Holm B, Thor Straten P, Mellemgaard A, Andersen MH, Svane IM. Long-lasting disease stabilization in the absence of toxicity in metastatic lung cancer patients vaccinated with an epitope derived from indoleamine 2,3 dioxygenase. Clin Cancer Res. 2014 Jan 1;20(1):221-32. doi: 10.1158/1078-0432.CCR-13-1560. Epub 2013 Nov 11.
Andersen MH. Immune Regulation by Self-Recognition: Novel Possibilities for Anticancer Immunotherapy. J Natl Cancer Inst. 2015 Jun 10;107(9):djv154. doi: 10.1093/jnci/djv154. Print 2015 Sep.
Other Identifiers
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2018-000139-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KEYNOTE-764
Identifier Type: OTHER
Identifier Source: secondary_id
IO102-012 / KN-764
Identifier Type: -
Identifier Source: org_study_id
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