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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am able to get out of my bed or chair and move around.
Select...
My cancer is advanced and the primary source is unknown despite tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR) [Efficacy]
Secondary outcome measures
Disease control rate (DCR)
Duration of response (DOR)
Number of participants with Treatment-Emergent Adverse Events [Safety]
+3 moreSide effects data
From 2023 Phase 3 trial • 397 Patients • NCT0360753974%
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
9%
Weight increased
8%
Pneumonia
8%
Amylase increased
8%
Blood creatinine increased
8%
Weight decreased
8%
Oedema peripheral
8%
Hypophagia
8%
Hepatic function abnormal
7%
Abdominal distension
7%
Productive cough
6%
Haemoglobin decreased
6%
Blood thyroid stimulating hormone increased
6%
Chest discomfort
6%
Hiccups
6%
Hyperthyroidism
6%
Blood alkaline phosphatase increased
6%
Hypoproteinaemia
6%
Hyperglycaemia
6%
Headache
5%
Urinary tract infection
5%
Hypertriglyceridaemia
5%
Tachypnoea
5%
Hypercholesterolaemia
5%
Haematuria
5%
Dyspnoea
5%
Hypoaesthesia
5%
Back pain
5%
Hypertension
4%
Haemoptysis
4%
Pain in extremity
2%
Immune-mediated pneumonitis
2%
Pneumonitis
1%
Respiratory failure
1%
Thrombocytopenia
1%
Abdominal pain
1%
Upper gastrointestinal haemorrhage
1%
Pleural effusion
1%
Interstitial lung disease
1%
Atrial fibrillation
1%
Cardiac failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sintilimab Combination
Placebo Combination
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
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,225 Total Patients Enrolled
Innovent Biologics (Suzhou) Co. Ltd.Industry Sponsor
167 Previous Clinical Trials
25,765 Total Patients Enrolled
Kanwal RaghavPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
340 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs and bone marrow are functioning well.I cannot tolerate or did not respond to at least one chemotherapy treatment.I have not taken any cancer treatments in the last 2 weeks.I have had a blood clot in an artery in the last 6 months.I have heart failure or irregular heartbeats that cause symptoms.I have had a serious blood clot in the past 3 months.I have a health condition or mental disorder that could affect my study participation.I have brain metastases or cancer in the lining of my brain.I have a serious infection that is not under control.I have not had major surgery in the last 4 weeks and am not scheduled for any during the trial.I have severe liver problems including encephalopathy, kidney issues, or advanced cirrhosis.I am significantly malnourished.I am taking corticosteroids for my lung disease.I can provide tissue samples for testing.I am able to get out of my bed or chair and move around.I have active hepatitis B or C.I have had cancer other than my current diagnosis.I have active tuberculosis in my lungs.I have a known history of primary immunodeficiency diseases.I received treatment to ease symptoms for a local cancer spot within the last 2 weeks.My cancer is advanced and the primary source is unknown despite tests.I have been treated with drugs that boost my immune system to fight cancer.I do not have any uncontrolled health issues that could increase my medical risks.I have severe lung problems.My high blood pressure is not controlled despite taking medication.I have a bowel obstruction or a history of certain diseases.I have an active autoimmune disease or had one within the last 2 years.I have had a gastrointestinal perforation or fistula in the last 6 months.My cancer has spread to my bones, and I am at risk of losing the ability to move my legs.I have had an organ or stem cell transplant from another person.I have not had a live vaccine in the last 4 weeks and won't get one during the study.I still have side effects from cancer treatment that are not mild.I cannot undergo standard cancer treatments and my cancer returned more than 3 months after my last treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (sintilimab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people with the applicable health conditions still able to enroll in this research project?
"The clinicaltrials.gov listing for this study says that it is recruiting patients right now. The trial was originally posted on 8/26/2021, and the most recent edit to the posting was on 7/31/2022."
Answered by AI
When will Sintilimab be cleared for general use?
"Sintilimab has yet to be proven effective in clinical trials, however, there is some data supporting its safety. For this reason, it received a score of 2."
Answered by AI
How many patients are being enrolled in this clinical trial?
"Yes, this trial is recruiting patients according to the latest information on clinicaltrials.gov. The listing for this study was first created on 8/26/2021 and updated most recently on 7/31/2022. Currently, the researchers are looking to enroll 45 individuals at a single location."
Answered by AI
Is this clinical trial novel in terms of its design or purpose?
"Sintilimab has been under study since 2017 when the first 290-patient trial was conducted by Innovent Biologics (Suzhou) Co. Ltd.. After that initial Phase 3 drug approval in 2017, there are now 145 active trials for Sintilimab being held across 86 cities and 10 countries."
Answered by AI
What other research studies have there been on Sintilimab?
"Currently, there are 145 clinical trials being conducted that involve Sintilimab. Out of these, 18 have reached Phase 3. The majority of these studies originate from Beijing but Sintilimab is being trialed in 237 different locations worldwide."
Answered by AI
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