Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Experimental tumor injection trial halted early

NCT ID NCT03871348

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage trial tested an experimental drug called SAR441000, injected directly into tumors, either alone or with another drug (cemiplimab) given through a vein. The study aimed to find a safe dose and see if the combination could shrink tumors in people with advanced solid cancers like melanoma. However, the trial was terminated early, so full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAR441000 (injected into tumors) and cemiplimab (given intravenously)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is a very early (Phase 1) trial that was terminated, so results are limited. The approach is experimental and may not prove safe or effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

77 people

The number who actually took part.

Started

Jan 2019

Finished

Feb 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * At least 18 years of age * Advanced solid tumors including lymphomas for which no standard alternative therapy is available (escalation phase). * Advanced melanoma (Stage IIIB-C or Stage IV, anti-PD-1/PD-L1 treated or not) or anti-PD-1/PD-L1 not treated advanced Head and Neck Squamous Cell Cancer or anti-PD-1/PD-L1 not treated Advanced Cutaneous Squamous Cell Cancer where no other alternative treatment option exists (expansion phases). * Minimum 3 lesions enrollment. * Injectable disease (i.e., suitable for direct intratumoral injection based on the dose level volume of each cohort and cumulative lesion size; according to the investigator's judgement). * A lesion amenable for additional tumor biopsy. * Patients with measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. * Life expectancy more than 3 months. * Willingness to provide mandatory tumor biopsy. * Male and female patients who agree to use effective contraceptive methods. * Signed informed consent. Exclusion criteria: * Eastern Cooperative Oncology Group (ECOG) performance score \>1. * Significant and uncontrolled concomitant illness that would adversely affect the patient's participation in the study. * Any prior organ transplantation. * History within the last 5 years of an invasive malignancy other than the one treated in this study, with the exception of resected basal or squamous-cell skin cancer or carcinoma, in situ of cervix or other local tumors considered cured by local treatment. * History of unresolved viral hepatitis; systemic immune suppression including acquired immunodeficiency syndrome (AIDS) related illnesses or human immunodeficiency virus (HIV) disease requiring antiretroviral treatment. * Prior splenectomy. * New and progressive brain lesions. * Poor bone marrow reserve resulting in low blood cell count. * Poor liver and kidney functions, abnormal coagulation tests. * Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments. * Maintenance therapy with prednisolone \>7.5 mg/day orally or equivalent during the study. * Non-resolution of any prior treatment related toxicity to Grade \<2, except alopecia, vitiligo, fatigue and hypothyroidism controlled with replacement therapies. * Moderate to severe immune related adverse event to prior immune-modulating agents within 90 days prior to the first study treatment. * Central nervous system lymphoma. * Prior allogeneic hematopoietic stem cell transplantation (HSCT) for patients with lymphoma. * Autologous HSCT less than 90 days prior to initiation of study intervention. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced cutaneous squamous cell carcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma lymphoma metastatic melanoma metastatic neoplasm neoplasm Neoplasm Metastasis skin squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic neoplasm

Contacts and locations

Locations

  • Cleveland Clinic - Cleveland- Site Number : 8400007

    Cleveland, Ohio, 44195, United States

  • Dana-Farber Cancer Institute- Site Number : 8400003

    Boston, Massachusetts, 02215, United States

  • Investigational Site Number : 0560001

    Brussels, 1200, Belgium

  • Investigational Site Number : 0560002

    Leuven, 3000, Belgium

  • Investigational Site Number : 0560003

    Ghent, 9000, Belgium

  • Investigational Site Number : 2500001

    Villejuif, 94805, France

  • Investigational Site Number : 2500002

    Paris, 75010, France

  • Investigational Site Number : 2500004

    Marseille, 13885, France

  • Investigational Site Number : 2760001

    Mainz, 55131, Germany

  • Investigational Site Number : 2760003

    Mannheim, 68167, Germany

  • Investigational Site Number : 2760004

    Heidelberg, 69120, Germany

  • Investigational Site Number : 2760005

    Hamburg, 20246, Germany

  • Investigational Site Number : 2760006

    Tübingen, 72076, Germany

  • Investigational Site Number : 5280001

    Rotterdam, 3015 CE, Netherlands

  • Investigational Site Number : 5280002

    Nijmegen, 6525 GA, Netherlands

  • Investigational Site Number : 7240001

    Pamplona, Navarre, 31008, Spain

  • Investigational Site Number : 7240002

    Valencia, 46014, Spain

  • Investigational Site Number : 7240004

    Barcelona, Catalunya [Cataluña], 08036, Spain

  • The University of Texas MD Anderson Cancer Center- Site Number : 8400002

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.