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: 3

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called sintilimab for individuals with Cancer of Unknown Primary (CUP), where the cancer's origin remains unidentified. The trial aims to assess the effectiveness and safety of sintilimab for patients who did not respond well to previous chemotherapy. Participants should have CUP that cannot be surgically removed or treated with radiation and must have tried at least one standard treatment. For those whose cancer treatments have failed and whose cancer's primary site is unknown, this trial might be suitable. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received certain treatments like systemic immunosuppressants or specific cancer therapies within 2 weeks before starting the trial.

Is there any evidence suggesting that sintilimab is likely to be safe for humans?

Research has shown that sintilimab, a type of cancer treatment, has been tested in various studies for different cancers, including cancer of unknown primary (CUP). In earlier trials, sintilimab helped shrink tumors in some CUP patients. The side effects resembled those of other treatments, allowing most patients to handle them well.

One study found that when combined with other drugs, sintilimab produced promising results and had manageable side effects for patients with advanced cancers. This suggests that sintilimab is generally well-tolerated, though side effects can occur, as with any cancer treatment.

Since this trial is in Phase 2, early testing has indicated that sintilimab is safe enough for more participants. However, participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Sintilimab is unique because it targets the PD-1 pathway, which is a different approach compared to the traditional chemotherapy and radiation treatments typically used for cancer of unknown primary. Most standard treatments focus on attacking cancer cells directly, but sintilimab works by unleashing the immune system to recognize and fight cancer cells more effectively. This immunotherapy approach has the potential to offer a more personalized treatment option with potentially fewer side effects. Researchers are excited about sintilimab because it could provide a new avenue for patients who have limited options and improve outcomes by enhancing the body's natural immune response to cancer.

What evidence suggests that sintilimab might be an effective treatment for cancer of unknown primary?

Research has shown that sintilimab, a type of immune therapy, offers promising results for treating cancer of unknown primary (CUP). In one study, sintilimab helped shrink or slow tumor growth in some CUP patients. Another study found that patients treated with immune checkpoint inhibitors like sintilimab lived longer than those who did not, with an average survival time of 17.3 months. Additionally, sintilimab has been linked to a good response rate and longer periods without cancer progression. These findings suggest that sintilimab could effectively manage CUP. ^{1 6 7 8 9}

Who Is on the Research Team?

Kanwal P. Raghav

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sintilimab at 200 mg via IV administration every 3 weeks until progression or other discontinuation criteria are met, for a maximum of 24 months

24 months

Every 3 weeks

Tumor Imaging Evaluation

Tumor imaging evaluation performed every 9 weeks based on RECIST 1.1

Every 9 weeks

Follow-up

Safety and survival follow-up after treatment completion or discontinuation

6 months

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.825

Phase II trial of sintilimab in cancer of unknown primary. Conclusions: Anti-PD1 therapy with Sintilimab demonstrated significant anti-tumor activity for select patients with refractory CUP with safety ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12357449/

Clinical efficacy of immune checkpoint inhibitors for cancer ... The median overall survival (OS) was 17.3 months. The OS of the ICIs-treated group was significantly longer than that of the non-ICIs group in ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-08870

Sintilimab for the Treatment of Patients with Unresectable, ... This phase II trial studies the side effects of sintilimab in treating patients with cancer of unknown primary that cannot be be removed by surgery ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11797612/

Sintilimab with chemotherapy as first-line treatment for ... The overall response rate was 59.4% in arm A and 40.0% in arm B. The median progression-free survival was 13.9 months (95% confidence interval [CI], 6.9–21.0) ...

5. jitc.bmj.com jitc.bmj.com/content/12/8/e009355

Five-year follow-up of neoadjuvant PD-1 inhibitor ... The 5-year OS rate is 80.4% and the 5-year DFS rate is 65.7%, implying the long-term survival benefits of neoadjuvant sintilimab monotherapy for ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05024968

NCT05024968 | Sintilimab in Cancer of Unknown Primary 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.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9580245/

Meta-analysis of the efficacy and safety of sintilimab for ... Sintilimab is now being tested in various stage I, II and III clinical studies in China to treat a range of solid malignancies, including NSCLC and esophageal ...

8. nature.com nature.com/articles/s41598-021-98937-2

Therapeutic effectiveness and safety of sintilimab ... This study aimed to evaluate the effectiveness and safety of sintilimab, a programmed cell death protein-1 (PD-1) blockade, combined with sorafenib and ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2589537023004510

Efficacy and safety of sintilimab plus albumin-bound- ... Sintilimab plus nab-paclitaxel treatment shows promising antitumor activity and manageable toxicity in patients with advanced cervical cancer.