Phase 2
N=10
Sintilimab in Cancer of Unknown Primary
Cancer of Unknown Primary Site
Bottom Line
View on ClinicalTrials.gov: NCT05024968 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Confirmed Objective Response Rate (cORR) by RECISTv1.1 — 40 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sintilimab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmed Objective Response Rate (cORR) by RECISTv1.1 |
40 | — |
| SECONDARY Progression-free Survival (PFS) |
4.4 | — |
| SECONDARY Overall Survival (OS) |
25.4 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Has histopathologically confirmed unresectable, locally advanced, recurrent or metastatic CUP. Patients must have undergone standard work-up to attempt to identify the primary tumor prior to enrollment.
- Is refractory or intolerant to at least one line of systemic chemotherapy. Patient ineligible for cytotoxic chemotherapy due to contraindications will be eligible.
- Has an ECOG PS of 0 - 2.
- Must be unsuitable for definitive treatment, such as definitive chemoradiotherapy and/or surgery. For subjects who have received (neo)adjuvant or definitive chemotherapy/chemoradiotherapy, time from the completion of last treatment to disease recurrence must be > 3 months.
- Is able to provide archival or fresh tissues for correlative analysis with obtainable results.
- Has at least one measurable lesion as per RECIST v1.1.
- Has adequate organ and bone marrow functions, as defined below:
- Complete blood count: absolute neutrophil count (ANC) ≥ 1.0 × 109/L, platelet (PLT) count ≥ 75 × 109/L, hemoglobin (HGB) ≥ 9.0 g/dL. Note: Subjects cannot receive blood transfusion, erythropoietin (EPO), or Granulocyte-colony stimulating factor (GSF) within 7 days prior to the blood collection.
- Hepatic function: total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN in subjects without hepatic metastasis; TBIL ≤ 1.5 × ULN, ALT and AST ≤ 5 × ULN in subjects with hepatic metastasis.
Exception: Patients with known Gilbert disease: serum bilirubin level ≤ 3 × ULN.
- Renal function: urine protein 200 IU/mL), or acute or chronic active hepatitis C (positive hepatitis C [HCV] antibody and detectable HCV RNA).
- Has history of gastrointestinal (GI) perforation and/or fistula within 6 months prior to study enrollment (having a gastrostomy or enterostomy is allowed).
- Has interstitial lung disease requiring corticosteroids.
- Has history of other primary malignant tumors, excluding:
- Malignant tumors that achieved a complete response (CR) at least 2 years prior to enrollment and expected to require no treatment during the trial.
- Adequately treated nonmelanoma skin cancer or lentigo maligna with no sign of disease recurrence.
- Adequately treated carcinoma in situ with no sign of disease recurrence.
- Prostate cancer, CLL or other cancers where the indolent nature of tumor allows for and patient is under active surveillance.
- Is pregnant or breastfeeding.
- Has an acute or chronic diseases, psychiatric disorders, or laboratory abnormality that may lead to the following consequences: increased investigational drug-related risks, or interference with interpretation of trial results, or is otherwise considered ineligible for participating in the trial by the investigators.
Data sourced from ClinicalTrials.gov (NCT05024968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.