Recruiting
Phase 1
Phase 2

ACTengine® IMA203 & Nivolumab

Sponsor:

Immatics US, Inc.

Code:

NCT03686124

Conditions

Refractory Cancer

Recurrent Cancer

Solid Tumor, Adult

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IMA203 Product

IMA203 product- flat dose

IMA203CD8 Product

Nivolumab

IMADetect®

Study Details

Brief summary:

The study's purpose is to establish the safety and tolerability of IMA203/IMA203CD8 products with or without combination with nivolumab in patients with solid tumors that express preferentially expressed antigen in melanoma (PRAME).

Conditions

Refractory Cancer

Recurrent Cancer

Solid Tumor, Adult

Cancer

Study ID

NCT03686124

Start date

May 14, 2019

Status verified date

May, 2026

Completion date

Jun, 2032

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must have recurrent/progressing and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatment.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • HLA-A\*02:01 positive
  • For patients with ovarian/fallopian tube cancer only: Patients must have confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.
  • For patients with endometrial carcinoma only: Patients must have a histologically confirmed diagnosis of recurrent or persistent endometrial carcinoma.
  • Measurable disease according to RECIST 1.1
  • Adequate selected organ function per protocol
  • Patient's tumor must express tumor antigen by "IMADetect® RT-qPCR. Retrospective testing will be required for patients that qualify.
  • Life expectancy more than 5 months
  • Female patient of childbearing potential must use adequate contraception prior to study entry until 12 months after the infusion of IMA203/IMA203CD8
  • Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203/IMA203CD8
  • The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to lymphodepletion.

Exclusion Criteria:

  • History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years
  • Pregnant or breastfeeding
  • Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents.
  • History of cardiac conditions as per protocol
  • Prior stem cell transplantation or solid organ transplantation
  • Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
  • History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician
  • Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
  • Patients with LDH greater than 2.0-fold ULN.
  • Any condition contraindicating leukapheresis, lymphodepletion, low-dose IL-2, and/or IMA203/IMA203CD8 treatment
  • Patients with active brain metastases
  • Concurrent treatment in another clinical trial.
  • For nivolumab treatment, patients must not have a history of severe immune-related toxicities, defined as any Grade 3 or 4 toxicities related to prior PD1/PD-L1 inhibitor therapy (e.g., atezolizumab, pembrolizumab or nivolumab etc.).

Other protocol defined inclusion/exclusion criteria could apply

Study Design

Enrollment

375 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation A (closed to enrollment)

Dose escalation of IMA203

experimental: Extension Cohort A

IMA203 at RP2D

experimental: Extension Cohort B (closed to enrollment)

IMA203 at RP2D + nivolumab

experimental: Extension Cohort AA

IMA203 at final RP2D (flat dose)

experimental: Uveal Melanoma

IMA203 at RP2D

experimental: Dose Escalation B

Dose escalation of IMA203CD8

experimental: Extension Cohort C

IMA203CD8 at dose levels confirmed to be safe

experimental: Extension Cohort D

IMA203CD8 at dose levels confirmed to be safe; without IL-2

experimental: Ovarian

IMA203CD8 monotherapy at dose levels confirmed to be safe

experimental: Endometrial

IMA203CD8 monotherapy at dose levels confirmed to be safe

experimental: Head and Neck, Lung, and Triple Negative Breast Cancer

IMA203CD8 monotherapy at dose levels confirmed to be safe

experimental: Rare Cancers

IMA203CD8 monotherapy at dose levels confirmed to be safe

Interventions

IMA203 Product

The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula

IMA203 product- flat dose

The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells

IMA203CD8 Product

The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula

Nivolumab

Nivolumab will be given post IMA203/IMA203CD8 infusion, after hematologic recovery is achieved. Clinical supply provided by Bristol Myers Squibb.

IMADetect®

IMADetect® is developed as a companion diagnostic to aid in selecting patients with relapsed and/or refractory solid cancers who might be eligible for enrollment in Immatics clinical trials.

Primary outcome measure

  • Phase 1: Determine the MTD and/or recommended dose for extension for IMA203/IMA203CD8 [ Time Frame: 28 days ]
  • Phase 1 and Phase 2: Number and grade of treatment emergent adverse events and adverse events of special interest in subjects treated. [ Time Frame: 35 days ]
  • Phase 1 and Phase 2: Tumor Response [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Immatics US, Inc.

+1 346 204-5400ctgovinquiries@immatics.com

Locations

Stanford Cancer Institute

Recruiting

Stanford, California, United States, 94305

Contacts

Allison Warner, MD

allison.betof@stanford.edu

University of Colorado, Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Sapna Patel, MD

720-848-0000

University of Miami Hospital and Clinics

Recruiting

Miami, Florida, United States, 33136

Contacts

305-243-2647CRSCutaneous@miami.edu

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Oldadapo O. Yeku, MD. PhD

617-643-6158

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Alexander Shoushtari, MD

646-888-4161shoushta@mskcc.org

Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run

Recruiting

Columbus, Ohio, United States, 43026

Contacts

Casey Cosgrove, MD

Casey.Cosgrove@osumc.edu

University of Pennsylvania, Perelamn Center for Advanced Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Janos Tanyi, MD, PhD

Janos.Tanyi@pennmedicine.upenn.edu

Thomas Jefferson University, Honickman Center

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Rino Seedor, MD

215-847-7409Rino.Seedor@jefferson.edu

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Contacts

Anthony Olszanski, MD, RPh

Anthony.Olszanski@fccc.edu

Principal Investigator:

Anthony Olszanski, MD

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Diwakar Davar, M.D.

412-623-7368davard@upmc.edu

Principal Investigator:

Jason Luke, M.D.

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Dejka M Araujo, M.D.

713-792-3626daraujo@mdanderson.org

Principal Investigator:

Dejka M Araujo, M.D.

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Sylvia Lee, MD

leesm@uw.edu

More Information

Sponsor

Immatics US, Inc.

Last update posted

May 13, 2026

Last verified

May, 2026

Keywords

  • T-cell therapy
  • immunotherapy
  • Melanoma (Skin)
  • Melanoma, Uveal
  • Ovarian Carcinoma
  • Uterine Carcinoma
  • Uterine Carcinosarcoma
  • Immatics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Immatics US, Inc. on 2026-05-13.