IMM60 and Pembrolizumab in Melanoma and NSCLC
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.
Checked against the public recordLast updated Apr 24, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- iOx Therapeutics
- Interventions being studied
- Drug: IMM60; Drug: Pembrolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * 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: 1. Not a woman of childbearing potential (WOCBP) 2. 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 Exclusion Criteria: * Has the following cardiac conditions: 1. Corrected QT interval (QTc) \> 450 ms 2. Uncontrolled hypertension with blood pressure (BP) \> 160/100 despite treatment 3. Class II or greater heart failure as defined by the New York Heart Association 4. 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- Dana-Farber Cancer Institute - MedicineBoston, Massachusetts
- Henry Ford Hospital - Internal MedicineDetroit, Michigan
- Rutgers, The State University of New Jersey - Robert Wood Johnson Medical School - The Cancer Institute of New Jersey (CINJ)New Brunswick, New Jersey
- Next VAFairfax, Virginia
- Institut Català d'Oncologia-Hospital Universitari Germans Trias i PujolBadalona, Barcelona
- Complexo Hospitalario Universitario A CoruñaA Coruña, Galicia
- Hospital Xeral Álvaro CunqueiroVigo, Pontevedra
- Hospital de La Santa Creu i Sant PauBarcelona
- Hospital Universitario 12 de OctubreMadrid
- Hospital Regional Universitario de MálagaMálaga
- Hospital Universitario Virgen De La MacarenaSeville
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 24, 2024. Always confirm current availability with the study team.