IMM60 and Pembrolizumab in Melanoma and NSCLC

Stopped early · Phase 1/Phase 2

Conditions studied: Non-small Cell Lung Cancer, Melanoma

In brief

The goal of this clinical trial is to learn about IMM60 with or without pembrolizumab in participants with advanced melanoma or non-small cell lung cancer. There are two phases: * Phase 1: This phase is designed to learn about the safety of IMM60 with or without pembrolizumab and to find a safe dose to test in Phase 2. * Phase 2: This phase is designed to learn whether IMM60 + pembrolizumab improves progression-free survival at 12 months compared to pembrolizumab alone in participants with non-small cell lung cancer.

Key facts

Study ID

NCT05709821

Run by

iOx Therapeutics

People needed

1

Starts

2023-11-15

Expected to finish

2024-04-22

Last updated by the study team

2024-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 to 1
• Adequate organ function
• At least 1 lesion, not previously irradiated, that can be accurately measured on CT or MRI as defined by RECIST 1.1 criteria
• NSCLC cohorts: Histologically confirmed diagnosis of stage IV NSCLC
• NSCLC cohorts: Patients with adenocarcinoma histology must not have sensitizing epidermal growth factor receptor (EGFR) or ROS proto-oncogene 1 (ROS1) mutations or anaplastic lymphoma kinase (ALK) translocations
• NSCLC cohorts: Participants in NSCLC arms must have a PD-L1 assessment (PD-L1 immuno-histochemistry (IHC) 22C3 pharmDx)
• Melanoma cohorts: Unresectable stage III or IV, histologically confirmed diagnosis of cutaneous or unknown primary melanoma
• Melanoma cohorts: B-type Raf proto-oncogene (BRAF) mutation status available
• Male participants: Participant must agree to use contraception and refrain from sperm donation during the treatment period and for at least 120 days after the last dose of study intervention
• Female participants: Participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
• Not a woman of childbearing potential (WOCBP)
• A WOCBP who agrees to follow contraceptive guidance during the treatment period and for at least 6 months after the last dose of study intervention

You may not qualify if…

• Has the following cardiac conditions:
• Corrected QT interval (QTc) > 450 ms
• Uncontrolled hypertension with blood pressure (BP) > 160/100 despite treatment
• Class II or greater heart failure as defined by the New York Heart Association
• Myocardial infarction within 6 months or angina requiring nitrate therapy more than once a week
• Another active malignancy within the past 2 years (Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder, or carcinoma in situ [e.g., breast carcinoma, cervical cancer in situ] that have undergone potentially curative therapy are not excluded. Also, prostate, breast, and neuroendocrine tumors that are stable on hormonal treatment for a period of 1 year or more without the need to adjust dose are not excluded.)
• Has had an allogeneic tissue/solid organ transplant
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable.
• History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Participants with an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids (in dosing exceeding 10 mg daily of prednisone equivalent) or immunosuppressive agents.
• Participants who are known to be serologically positive for Hepatitis B, Hepatitis C, or human immunodeficiency virus.

Where it is running

• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Dana-Farber Cancer Institute - Medicine — Boston, Massachusetts, United States
• Henry Ford Hospital - Internal Medicine — Detroit, Michigan, United States
• Rutgers, The State University of New Jersey - Robert Wood Johnson Medical School - The Cancer Institute of New Jersey (CINJ) — New Brunswick, New Jersey, United States
• Next VA — Fairfax, Virginia, United States
• Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol — Badalona, Barcelona, Spain
• Complexo Hospitalario Universitario A Coruña — A Coruña, Galicia, Spain
• Hospital Xeral Álvaro Cunqueiro — Vigo, Pontevedra, Spain
• Hospital de La Santa Creu i Sant Pau — Barcelona, Spain
• Hospital Universitario 12 de Octubre — Madrid, Spain
• Hospital Regional Universitario de Málaga — Málaga, Spain
• Hospital Universitario Virgen De La Macarena — Seville, Spain
• H. Clínico de Valencia — Valencia, Spain
• Nottingham University Hospital - Oncology — Nottingham, United Kingdom

Full record on ClinicalTrials.gov

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