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Promising cancer combo trial halted early – no clear answers yet

NCT ID NCT05061420

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tested a new drug called SAR444245 combined with either pembrolizumab or cetuximab in 59 adults with head and neck cancer that had spread or come back. The goal was to see if the combinations could shrink tumors. However, the study was terminated early, so we don't have enough information to know if the treatments work or are safe.

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 pembrolizumab or cetuximab
What this could lead to
If it had worked, this could have pointed toward a new treatment option for head and neck cancer that doesn't respond to standard therapy.
What could go wrong
The study was terminated early, so we don't have enough data to know if the combination is effective or safe. Early-phase trials often fail to show benefit.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

59 people

The number who actually took part.

Started

Oct 2021

Finished

Nov 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: -Participants were ≥ 18 years of age inclusive, at the time of signing the informed consent * Histologically or cytologically confirmed diagnosis of R/M HNSCC that was considered not amenable to further therapy with curative intent. The eligible primary tumor locations were oropharynx, oral cavity, hypopharynx, and larynx (nasopharynx is excluded). * Measurable disease. * Baseline biopsy was submitted for all cohort A1 Core Phase participants. * Baseline biopsy was submitted for all cohort B1, B2 Expansion Phase participants. * Known HPV p16 status for oropharyngeal cancer. * Participant agreed to follow protocol-specified contraception guidelines. Exclusion Criteria: -Eastern Cooperative Oncology Group (ECOG) performance status of ≥2 * Had received prior IL2-based anticancer treatment. -For participants in Cohort A1: Prior treatment with an agent (approved or investigational) that blocks the PD-1/PD-L1 pathway (participants who joined a study with an anti-PD-1/PD-L1 in the experimental arm but have written confirmation they have not received anti-PD-1/PD-L1 are allowed). * For participants in Cohort B2: Prior treatment with cetuximab (prior cetuximab allowed if used for the treatment of locally advanced disease, with no progressive disease for at least 4 months from completion of prior cetuximab therapy). * For participants in Cohort B2: Electrolytes (magnesium, calcium, potassium) outside the normal ranges. * Participants under anti-hypertensive treatment who cannot temporarily (for at least 36 hours) withhold antihypertensive medications prior to each IMP dosing. * Participants with baseline SpO2 ≤92% (without oxygen therapy). * Comorbidity requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 2 weeks of IMP initiation. Inhaled or topical steroids are permitted, provided that they were not for treatment of an autoimmune disorder. Participants who require a brief course of steroids (eg, as prophylaxis for imaging studies due to hypersensitivity to contrast agents) were not excluded.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

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

Squamous cell carcinoma of head and neck

Contacts and locations

Locations

  • City of Hope- Site Number : 8400007

    Duarte, California, 91010, United States

  • Investigational Site Number : 0320001

    Buenos Aires, 1012, Argentina

  • Investigational Site Number : 1240001

    Montreal, Quebec, H4A 3J1, Canada

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8420383, Chile

  • Investigational Site Number : 1520002

    Temuco, 4800827, Chile

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7500921, Chile

  • Investigational Site Number : 1520004

    Viña del Mar, Valparaiso, 2540488, Chile

  • Investigational Site Number : 1580003

    Tainan, 704, Taiwan

  • Investigational Site Number : 2500001

    Villejuif, 94800, France

  • Investigational Site Number : 2500002

    Strasbourg, 67033, France

  • Investigational Site Number : 2500003

    Bordeaux, 33075, France

  • Investigational Site Number : 2500006

    Paris, 75015, France

  • Investigational Site Number : 2500008

    Lyon, 69008, France

  • Investigational Site Number : 2760004

    Berlin, 12200, Germany

  • Investigational Site Number : 3800003

    Brescia, 25123, Italy

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 06351, South Korea

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 05505, South Korea

  • Investigational Site Number : 5280001

    Nijmegen, 6500 HB, Netherlands

  • Investigational Site Number : 5280002

    Amsterdam, 1066, Netherlands

  • Investigational Site Number : 7240001

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7240003

    Madrid, Madrid, Comunidad de, 28046, Spain

  • Investigational Site Number : 7240004

    Barcelona, Barcelona [Barcelona], 08036, Spain

  • Investigational Site Number : 7240005

    Madrid, Madrid, Comunidad de, 28040, Spain

  • Seattle Cancer Care Alliance Site Number : 8400006

    Seattle, Washington, 98115, United States

  • Thomas Jefferson University Hospital Site Number : 8400003

    Philadelphia, Pennsylvania, 19107, United States

  • University of Colorado- Site Number : 8400004

    Aurora, Colorado, 80045, United States

  • University of Michigan- Site Number : 8400008

    Ann Arbor, Michigan, 48109, United States

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