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New combo aims to boost immunotherapy in elderly melanoma patients

NCT ID NCT07644897

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tests whether adding thymosin alpha 1 to the immunotherapy drug toripalimab can help elderly patients (60+) with advanced melanoma. The study will enroll 55 participants and measure how many patients' tumors shrink or disappear. Researchers also want to see if the combination is safer and better tolerated than standard treatments.

What this could mean

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

Active substance
Thymosin alpha 1 and toripalimab (anti-PD-1 antibody)
What this could lead to
If it works, this combination could offer a safer, more effective treatment option for elderly patients with advanced melanoma who cannot tolerate standard therapies.
What could go wrong
This is a small, early-phase, single-arm trial with no control group, so results may not be conclusive. The combination may not improve outcomes and could still cause side effects.

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

About 55 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

60 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: 1. Aged 60 years or older; 2. Diagnosis of malignant melanoma confirmed by pathological histology or cytology examination. 3. According to the 8th edition of AJCC staging, patients with unresectable stage III or IV melanoma; 4. One or more lesions evaluable by RECIST1.1 standards. 5. The Eastern Cooperative Oncology Group (ECOG) scoring system in the United States has a score range of 0-2. 6. Total bilirubin ≤1.5× upper limit of normal (ULN); AST and AST \<2.5× upper limit of normal (ULN).(No liver metastasis), or \<5 times the upper limit of normal (ULN) (with liver metastasis); 7. Patients with recurrent metastasis who have not previously received immunotherapy such as PD-1, PD-L1, CTLA-4 antibodies,also allowed for the enrollment of patients who had used adjuvant/neoadjuvant therapies * If the adjuvant or neoadjuvant treatment plan includes PD(L)-1 or CTLA-4 monoclonal antibodies, it is required that only those who progress more than 6 months after the end of the treatment plan can be included in the study group. * If the adjuvant or neo-adjuvant treatment plan does not include PD(L)-1 or CTLA-4 monoclonal antibodies, patients who progress during the adjuvant treatment are allowed to participate in the study. 8. Has signed the informed consent form, able to comply with the study protocol and follow-up plan. Exclusion Criteria: 1. Received treatment involving PD-1, PD-L1, or CTLA-4 antibody regimen within the past 6 months; 2. Patients who have received treatment with thymosin, thymopentin, or thymosin a-1d within 3 months prior to enrollment. 3. Presence of symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. For subjects with previously treated CNS metastases, if the subject's condition is stable (no evidence of radiographic progression for at least weeks prior to the first administration of the study intervention, and all neurological symptoms have returned to baseline), repeat radiographic examination confirms no evidence of new brain metastases or enlargement of existing brain metastases, and no need for steroid treatment for at least 14 days prior to the first administration of the study intervention, they may participate in the study. 4. Patients with active systemic autoimmune diseases requiring systemic treatment (i.e., using immunomodulators, corticosteroids, or immunosuppressants). Replacement therapies (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered systemic treatment. 5. Has a history of immunodeficiency, including testing positive for HIV, or suffering from other acquired or congenital immunodeficiency diseases, or has a history of organ transplantation and bone marrow transplantation. 6)Allergic to the investigational drug or its components; 7)Presence of active infection requiring systemic treatment; 8) Uncontrolled internal medical complications, such as unstable congestive heart failure, unstable angina, myocardial infarction, cerebrovascular accidents, and hemodynamically unstable arrhythmias, etc. 9\) The investigator deems them unsuitable for inclusion.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Nanshan hospital

    RECRUITING

    Shenzhen, Guangdong, 518000, China

  • Sun yat-sen uniersity

    RECRUITING

    Guangzhou, Guangdong, 510000, China

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