Sintilimab for Cancer of Unknown Primary

Overseen By Alma DeLaGarza

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Immunosuppressants, Immunomodulators

Disqualifiers: Autoimmune disease, CNS metastasis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 2 clinical trial evaluating the efficacy and safety of sintilimab in subjects with CUP. Up to 45 subjects with CUP will be enrolled. Subjects will be treated with sintilimab at 200 mg via intravenous (IV) administration on Cycle 1 Day 1. The treatment will repeat every 3 weeks until progressive disease (PD), intolerable toxicity, initiation of new anti-tumor therapy, withdrawal of consent, lost to follow-up, death, completion of therapy, or any other investigator-determined reasons for treatment discontinuation (whichever occurs first). Treatment will continue for a maximum period of 24 months (starting from the first dose). During the trial, tumor imaging evaluation will be initially performed once every 9 weeks (± 7 days) and will be based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. After the completion or discontinuation of the study treatment, safety follow-up and survival follow-up will be performed. Considering the rareness of the disease, the patient accrual rate is expected to be approximately 2 patients per month. The total study duration is expected to be between 24-27 months with 6-month follow up.

Research Team

Kanwal P. Raghav

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with Cancer of Unknown Primary (CUP) who've had no luck with at least one chemotherapy, can't have surgery or definitive treatments, and are expected to live more than 12 weeks. They need a measurable tumor and good organ function but can't join if they're pregnant, have serious infections or immune diseases, recent major surgeries or vaccines, certain blood clots or liver problems.

Inclusion Criteria

Has at least one measurable lesion as per RECIST v1.1.

My organs and bone marrow are functioning well.

I cannot tolerate or did not respond to at least one chemotherapy treatment.

Exclusion Criteria

I have not taken any cancer treatments in the last 2 weeks.

Is pregnant or breastfeeding.

I have had a blood clot in an artery in the last 6 months.

Treatment Details

Interventions

• Sintilimab

Trial Overview The trial tests Sintilimab's effectiveness and safety in treating CUP. Participants will receive Sintilimab intravenously every three weeks up to two years unless the disease worsens or side effects become too severe. Tumor response is monitored using RECIST criteria through imaging every nine weeks initially.

Participant Groups

Group I: Treatment (sintilimab) Experimental Treatment 1 Intervention

The study drug is sintilimab. The first dose of study treatment should start on Day 1 of Cycle 1. For the rest of the treatment cycles, the study treatment can be administered 3 day before or 3 days after the scheduled day of administration. Treatment can be delayed for up to 1 week if the administration day is on a holiday or if the subject is otherwise unavailable.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Innovent Biologics (Suzhou) Co. Ltd.

Industry Sponsor

Trials

184

Recruited

28,300+

Dr. Michael Yu

Innovent Biologics (Suzhou) Co. Ltd.

Chief Executive Officer since 2011

PhD in Molecular Biology

Dr. Nageatte Ibrahim

Innovent Biologics (Suzhou) Co. Ltd.

Chief Medical Officer

MD