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Monoclonal Antibodies

Sintilimab for Cancer of Unknown Primary

Phase 2

Waitlist Available

Led By Kanwal Raghav

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has an ECOG PS of 0 - 2.

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.

Must not have

Has symptomatic congestive heart failure or symptomatic or poorly controlled arrhythmia.

Has known symptomatic central nervous system (CNS) metastasis or carcinomatous meningitis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug to treat cancer of unknown primary (CUP). The drug is given intravenously and treatment will continue for up to 24 months or until the patient can no longer tolerate the treatment, has progressive disease, or meets any other criteria for treatment discontinuation.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Sintilimab may cause immune-related reactions affecting various organs, infusion-related symptoms like fever and chills, fatigue, possible changes in blood counts leading to increased infection risk. The severity of side effects varies among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to get out of my bed or chair and move around.

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My cancer is advanced and the primary source is unknown despite tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have heart failure or irregular heartbeats that cause symptoms.

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I have brain metastases or cancer in the lining of my brain.

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I have a serious infection that is not under control.

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I have severe liver problems including encephalopathy, kidney issues, or advanced cirrhosis.

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I am significantly malnourished.

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I am taking corticosteroids for my lung disease.

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I have active hepatitis B or C.

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I have had cancer other than my current diagnosis.

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I have active tuberculosis in my lungs.

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I have a known history of primary immunodeficiency diseases.

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I have been treated with drugs that boost my immune system to fight cancer.

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I have severe lung problems.

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My high blood pressure is not controlled despite taking medication.

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I have a bowel obstruction or a history of certain diseases.

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I have an active autoimmune disease or had one within the last 2 years.

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My cancer has spread to my bones, and I am at risk of losing the ability to move my legs.

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I have had an organ or stem cell transplant from another person.

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I have not had a live vaccine in the last 4 weeks and won't get one during the study.

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I still have side effects from cancer treatment that are not mild.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2023 Phase 3 trial • 397 Patients • NCT03607539

74%

Anaemia

71%

Neutrophil count decreased

68%

White blood cell count decreased

42%

Platelet count decreased

41%

Aspartate aminotransferase increased

41%

Nausea

41%

Alanine aminotransferase increased

38%

Decreased appetite

33%

Asthenia

29%

Vomiting

27%

Constipation

21%

Pyrexia

20%

Hypoalbuminaemia

14%

Rash

13%

Lymphocyte count decreased

13%

Diarrhoea

12%

Cough

12%

Gamma-glutamyltransferase increased

11%

Insomnia

11%

Hypothyroidism

11%

Hypokalaemia

11%

Hyponatraemia

11%

Proteinuria

11%

Dizziness

10%

Upper respiratory tract infection

10%

Blood glucose increased

Weight increased

Pneumonia

Amylase increased

Blood creatinine increased

Weight decreased

Oedema peripheral

Hypophagia

Hepatic function abnormal

Abdominal distension

Productive cough

Haemoglobin decreased

Blood thyroid stimulating hormone increased

Chest discomfort

Hiccups

Hyperthyroidism

Blood alkaline phosphatase increased

Hypoproteinaemia

Hyperglycaemia

Headache

Tachypnoea

Urinary tract infection

Hypertriglyceridaemia

Hypercholesterolaemia

Haematuria

Dyspnoea

Hypoaesthesia

Back pain

Hypertension

Haemoptysis

Pain in extremity

Immune-mediated pneumonitis

Pneumonitis

Respiratory failure

Thrombocytopenia

Abdominal pain

Upper gastrointestinal haemorrhage

Pleural effusion

Interstitial lung disease

Atrial fibrillation

Cardiac failure

100%

80%

60%

40%

20%

Study treatment Arm

Sintilimab Combination

Placebo Combination

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (sintilimab)Experimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sintilimab

Not yet FDA approved

0 / 21Eligibility criteria met