IMM60 and Pembrolizumab in Melanoma and NSCLC

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedIMM60 and Pembrolizumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 24, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?14 U.S. locations

Locations may change over time.

Who runs it?iOx Therapeutics

Study sponsor

Study overview

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

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

Study sites

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.

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