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IO102 With Pembrolizumab, With or Without Chemotherapy, as First-line Treatment of Metastatic NSCLC

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ClinicalTrials.gov Identifier: NCT03562871
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : December 21, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
IO Biotech

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.


Condition or disease Intervention/treatment Phase
NSCLC Biological: IO102 Biological: pembrolizumab (Keytruda) Drug: Carboplatin (Carboplatin Kabi) Drug: Pemetrexed (Pemetrexed Alvogen) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 22, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Biological: IO102
test immunotherapy

Biological: pembrolizumab (Keytruda)
anti-PD-1 immunotherapy

Active Comparator: Cohort A2
Drug: pembrolizumab (Keytruda) 200 mg IV infusion on Day 1 of each 3 week cycle
Biological: pembrolizumab (Keytruda)
anti-PD-1 immunotherapy

Experimental: 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
Biological: IO102
test immunotherapy

Biological: pembrolizumab (Keytruda)
anti-PD-1 immunotherapy

Drug: Carboplatin (Carboplatin Kabi)
chemotherapy

Drug: Pemetrexed (Pemetrexed Alvogen)
chemotherapy

Active Comparator: 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
Biological: pembrolizumab (Keytruda)
anti-PD-1 immunotherapy

Drug: Carboplatin (Carboplatin Kabi)
chemotherapy

Drug: Pemetrexed (Pemetrexed Alvogen)
chemotherapy




Primary Outcome Measures :
  1. Phase 1 (safety run-in) [ Time Frame: One cycle i.e. 3 weeks ]
    Dose Limiting Toxicity graded per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

  2. Phase 2 (efficacy) [ Time Frame: 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 Outcome Measures :
  1. ORR [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562871


Contacts
Contact: Eva Dr Ehrnrooth, MD PhD +4570702980 ee@iobiotech.com
Contact: Anita Vedel Christiansen, MSc Pharm av@iobiotech.com

Locations
Spain
Servicio de Oncología-El médico del Virgen de la Victoria Recruiting
Málaga, Andalusia, Spain, 29010
Contact: José M Trigo Pérez, Dr         
Insituto Oncologico Dr Rosell. Hospital Universitario Quiron Dexeus Recruiting
Barcelona, Catalonia, Spain, 08028
Contact: Santiago Viteri, Prof         
Hospital Universitario de Vall d'Hebron Recruiting
Barcelona, Catalonia, Spain, 08035
Contact: Enriqueta Felip, Dr         
Hospital Universitari de Girona Doctor Josep Trueta Recruiting
Girona, Catalonia, Spain, 17007
Contact: Joaquim Bosch, Dr         
Hospital Universitario 12 Octubre Recruiting
Madrid, Community Of Madrid, Spain, 28041
Contact: Luis Paz-Ares, Dr         
Hospital Universitario HM Sanchinarro Recruiting
Madrid, Community Of Madrid, Spain, 28050
Contact: Castro Carpeño, Dr         
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Community Of Madrid, Spain, 28134
Contact: Pilar Garrido, Dr         
Hospital Puerta del Hierro Majadahonda Recruiting
Madrid, Community Of Madrid, Spain
Contact: Mariano Provencio, Dr         
Hospital Clinico Universitario de València Not yet recruiting
València, Horta De València, Spain, 46010
Contact: Amelia Insa, Dr         
Sponsors and Collaborators
IO Biotech
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: James Spicer, MD Prof Guys Hospital

Publications:

Responsible Party: IO Biotech
ClinicalTrials.gov Identifier: NCT03562871     History of Changes
Other Study ID Numbers: IO102-012 / KN-764
2018-000139-28 ( EudraCT Number )
KEYNOTE-764 ( Other Identifier: Merck Sharp & Dohme Corp )
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

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.


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by IO Biotech:
PD-1
PD-L1
Programmed Cell Death 1
Chemotherapy
Pemetrexed
Carboplatin
Pembrolizumab
Immunotherapy
IO102
Keytruda

Additional relevant MeSH terms:
Pembrolizumab
Carboplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors