IO102 With Pembrolizumab, With or Without Chemotherapy, as First-line Treatment of Metastatic NSCLC
An Open-label, Randomized, Phase I/II Trial Investigating the Safety and Efficacy of IO102 in Combination With Pembrolizumab, With or Without Chemotherapy, as First-line Treatment for Patients With Metastatic Non-Small Cell Lung Cancer
3 other identifiers
interventional
109
4 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2018
Typical duration for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2018
CompletedFirst Posted
Study publicly available on registry
June 20, 2018
CompletedStudy Start
First participant enrolled
August 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2022
CompletedApril 21, 2022
April 1, 2022
2.5 years
May 14, 2018
April 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase 1 (safety run-in)
Dose Limiting Toxicity graded per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
One cycle i.e. 3 weeks
Phase 2 (efficacy)
Objective Response Rate (ORR) evaluated by RECIST 1.1 and defined as the rate of complete response (CR) + partial response (PR)
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)
Secondary Outcomes (1)
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)
Study Arms (4)
Cohort A1
EXPERIMENTALDrug: 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
Cohort A2
ACTIVE COMPARATORDrug: pembrolizumab (Keytruda) 200 mg IV infusion on Day 1 of each 3 week cycle
Cohort B1
EXPERIMENTALDrug: 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
Cohort B2
ACTIVE COMPARATORDrug: 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IO Biotechlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (13)
Thoraxklinik Heidelberg gGmbH
Heidelberg, Community of Heidelberg, 69126, Germany
PIUS Hospital Oldenburg
Oldenburg, 26121, Germany
Stichting Het Nederlands Kanker Instituut
Amsterdam, Community of Amsterdam, Netherlands
Servicio de Oncología-El médico del Virgen de la Victoria
Málaga, Andalusia, 29010, Spain
Insituto Oncologico Dr Rosell. Hospital Universitario Quiron Dexeus
Barcelona, Catalonia, 08028, Spain
Hospital Universitario de Vall d'Hebron
Barcelona, Catalonia, 08035, Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Catalonia, 17007, Spain
Hospital Clinico Universitario de València
Valencia, Horta de València, 46010, Spain
Hospital Universitario 12 Octubre
Madrid, Madrid, 28041, Spain
Hospital Universitario HM Sanchinarro
Madrid, Madrid, 28050, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28134, Spain
Hospital Puerta del Hierro Majadahonda
Madrid, Madrid, Spain
Guy's Hospital
London, SE1 9RT, United Kingdom
Related Publications (4)
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.
PMID: 27745820BACKGROUNDReck 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.
PMID: 27718847BACKGROUNDIversen 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.
PMID: 24218513BACKGROUNDAndersen 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.
PMID: 26063792BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Spicer, MD Prof
Guy's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2018
First Posted
June 20, 2018
Study Start
August 22, 2018
Primary Completion
February 6, 2021
Study Completion
April 12, 2022
Last Updated
April 21, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share
All unpublished information relating to this trial and/or to the trial treatments is considered confidential by the Sponsor and shall remain the sole property of the Sponsor. The Investigator must accept that the Sponsor may use the information from this clinical trial in connection with the development of the IO102, and therefore, may disclose it as required to other Investigators, to government licensing authorities, to regulatory agencies of other governments, stock exchange market, and commercial partners.