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Treatment for recurrent and refractory solid tumors using engineered T-cells and nivolumab

Phase 1/2 Study Evaluating Genetically Modified Autologous T Cells Expressing a TCR Recognizing a Cancer/Germline Antigen as Monotherapy or in Combination With Nivolumab in Patients With Recurrent and/or Refractory Solid Tumors

Phase1; Phase2 Interventional Immatics US, Inc. · NCT03686124

This study is testing a new treatment using specially designed T-cells and a drug called nivolumab to see if it can help people with tough-to-treat solid tumors.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment375 (estimated)
Ages18 Years and up
SexAll
SponsorImmatics US, Inc. Industry-sponsored
Drugs / interventionsnivolumab, atezolizumab, pembrolizumab, cyclophosphamide, fludarabine
Locations21 sites (Stanford, California and 20 other locations)
Trial IDNCT03686124 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and tolerability of IMA203 and IMA203CD8, which are engineered T-cell therapies, either alone or in combination with nivolumab, for patients with recurrent or refractory solid tumors expressing the PRAME antigen. Eligible patients will undergo leukapheresis to collect white blood cells, which will be used to manufacture the T-cell products. Prior to infusion, patients will receive lymphodepletion therapy to enhance the effectiveness of the treatment. The study includes close monitoring of patients throughout the treatment and follow-up period, which lasts up to five years.

Who should consider this trial

Good fit: Ideal candidates include adults with recurrent or refractory solid tumors that express the PRAME antigen and who have limited treatment options.

Not a fit: Patients with other malignancies or those who do not express the required tumor antigen may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat solid tumors.

How similar studies have performed: Other studies utilizing engineered T-cell therapies have shown promising results, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Stanford, California and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Refractory CancerRecurrent CancerSolid Tumor, AdultCancerT-cell therapyimmunotherapyMelanomaMelanoma, Uveal
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.