Melanoma Clinical Trial

IMM60 and Pembrolizumab in Melanoma and NSCLC

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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Full Description

This exploratory phase 1/phase 2 study is designed to establish a recommended phase 2 dose of IMM60 and provide preliminary estimates of safety and efficacy of IMM60 alone and in combination with pembrolizumab in participants with NSCLC and melanoma. In phase 1, initial safety will be assessed in a multiple dose escalation cohort for IMM60 alone, then for the IMM60 + pembrolizumab combination. Phase 2 of the study will recruit PD-1 pretreated melanoma participants and randomize PD-L1 > 50% total NSCLC participants 2:1 to IMM60 + pembrolizumab vs pembrolizumab alone. There is an additional cohort of PD-L1 < 1% NSCLC participants.

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Eligibility Criteria

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:

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

Exclusion Criteria:

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.

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

1

Study ID:

NCT05709821

Recruitment Status:

Terminated

Sponsor:

iOx Therapeutics

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There are 14 Locations for this study

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USC Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Dana-Farber Cancer Institute - Medicine
Boston Massachusetts, 02215, United States
Henry Ford Hospital - Internal Medicine
Detroit Michigan, 48202, 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, 08901, United States
Next VA
Fairfax Virginia, 22031, United States
Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Complexo Hospitalario Universitario A Coruña
A Coruña Galicia, 15006, Spain
Hospital Xeral Álvaro Cunqueiro
Vigo Pontevedra, 36312, Spain
Hospital de La Santa Creu i Sant Pau
Barcelona , 08041, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Regional Universitario de Málaga
Málaga , 29011, Spain
Hospital Universitario Virgen De La Macarena
Sevilla , 41009, Spain
H. Clínico de Valencia
Valencia , 46010, Spain
Nottingham University Hospital - Oncology
Nottingham , NG5 1, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

1

Study ID:

NCT05709821

Recruitment Status:

Terminated

Sponsor:


iOx Therapeutics

How clear is this clinincal trial information?

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