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Experimental combo for skin cancer stalls as trial ends early

NCT ID NCT04913220

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested a new drug (SAR444245) combined with an existing immunotherapy (cemiplimab) in 46 adults with advanced melanoma or squamous cell skin cancer that could not be surgically removed. The goal was to see if the combination shrank tumors. However, the study was terminated early, so we have limited information on how well it worked or its safety.

What this could mean

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

Active substance
SAR444245 (THOR-707) combined with cemiplimab (Libtayo)
What this could lead to
If it had succeeded, this combination might have offered a new treatment option for people with advanced skin cancers that cannot be removed by surgery.
What could go wrong
The trial was terminated early, so we have very little data on whether the combination works or is safe. It is also a small, early-phase study, so even if completed, results would not be conclusive.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

46 people

The number who actually took part.

Started

Jul 2021

Finished

Feb 2025

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: * Participant must be ≥18 years of age (or country's legal age of majority if \>18 years), at the time of signing the informed consent. * Participants with: * Cohort A: Histologically confirmed unresectable locally advanced or metastatic melanoma that are not amenable to local therapy * Cohort B: Histologically confirmed metastatic CSCC or locally advanced * CSCC that are not candidates for curative surgery or radiation. Special considerations for the following categories: Participants with tumors arising on the cutaneous hair (non-glabrous) bearing lip with extension onto dry red lip (vermillion) may be eligible after communication with and approval from the Sponsor Participants with the primary site is nose are only eligible if the primary site was skin, not nasal mucosa with outward extension to skin (the Investigator confirmed) Participants with mixed histology in which the predominant histology is invasive CSCC may be eligible after communication with and approval from the Sponsor * Participants in both cohorts must have at least one measurable lesion * Provision of tumor tissue: For participants in the dose escalation: 16 µg/kg: at screening, biopsy is optional but highly recommended; and on-treatment not required 24 µg/kg: at screening, biopsy is mandatory and on-treatment, optional but highly recommended * For the other participants : Mandatory baseline biopsy for the participants to enroll in cohort A with skin metastasis and in cohort B. Mandatory on-treatment biopsy for participants in Cohort A with skin metastasis and participants in Cohort B. * Females are eligible to participate if they are not pregnant or breastfeeding, not a woman of childbearing potential (WOCBP) or are a WOCBP that agrees: to use approved contraception method and submit to regular pregnancy testing prior to treatment and for at least 180 days after discontinuing study treatment and to refrain from donating or cryopreserving eggs for 180 days after discontinuing study treatment. * Males are eligible to participate if they agree to refrain from donating or cryopreserving sperm, and either abstain from heterosexual intercourse OR use approved contraception during study treatment and for at least 210 days after discontinuing study treatment. * Capable of giving signed informed consent Exclusion Criteria: * Participants are excluded from the study if any of the following criteria apply: * Eastern Cooperative Oncology Group (ECOG) performance status of ≥2 * Poor organ function * Participants with baseline SpO2 ≤92% * Active brain metastases or leptomeningeal disease. * History of allogenic tissue/solid organ transplant. * Last administration of prior antitumor therapy or any investigational treatment within 28 days or less than 5 times the half-life, whichever is shorter; major surgery or local intervention within 28 days. * History of lung disease * Comorbidity requiring corticosteroid therapy * Antibiotic use (excluding topical antibiotics) ≤14 days prior to first dose of IMP * Severe or unstable cardiac condition within 6 months prior to starting study treatment * Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years * Known second malignancy either progressing or requiring active treatment within the last 3 years For both cohorts: * Prior immune checkpoint inhibitors except in the context of adjuvant or neoadjuvant; Participants who were on control arm of a study with an investigational anti-PD-1/PD-L1 are eligible. * Received adjuvant or neoadjuvant therapy during the 6 months prior to development of metastatic disease. * For Cohort A: any prior systemic treatment for advanced/metastatic disease * For Cohort B: \>2 prior lines of any systemic treatment for advanced/metastatic disease * Inability to undergo any contrast-enhanced radiologic response assessment * Receipt of a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

melanoma skin squamous cell carcinoma

As listed by the trial registrant

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

Malignant melanoma Squamous cell carcinoma of skin

Contacts and locations

Locations

  • Beverly Hills Cancer Center & Optima Diagnostic Imaging Site Number : 8400007

    Beverly Hills, California, 90211, United States

  • Investigational Site Number : 0360001

    Macquarie University, New South Wales, 2109, Australia

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8420383, Chile

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7500921, Chile

  • Investigational Site Number : 1520003

    Temuco, 4800827, Chile

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana de Santiago, Chile

  • Investigational Site Number : 1520005

    Santaigo, Reg Metropolitana de Santiago, 8241470, Chile

  • Investigational Site Number : 1520006

    Antofagasta, 1420000, Chile

  • Investigational Site Number : 2500001

    Nantes, 44093, France

  • Investigational Site Number : 2500002

    Dijon, 21079, France

  • Investigational Site Number : 2500003

    Bobigny, 93009, France

  • Investigational Site Number : 2500005

    Lille, 59037, France

  • Investigational Site Number : 2500006

    Pierre-Bénite, 69495, France

  • Investigational Site Number : 2760001

    Hamburg, 20246, Germany

  • Investigational Site Number : 2760003

    Mannheim, 68167, Germany

  • Investigational Site Number : 2760004

    Berlin, 10117, Germany

  • Investigational Site Number : 2760005

    München, 80337, Germany

  • Investigational Site Number : 2760006

    Minden, 32429, Germany

  • Investigational Site Number : 3800001

    Naples, 80131, Italy

  • Investigational Site Number : 3800004

    Perugia, 06126, Italy

  • Investigational Site Number : 7240001

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7240002

    Santander, Cantabria, 39008, Spain

  • Investigational Site Number : 7240003

    L'Hospitalet de Llobregat, Barcelona [Barcelona], 08908, Spain

  • Investigational Site Number : 7240004

    Barcelona, Barcelona [Barcelona], 08036, Spain

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