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Monoclonal Antibodies

Tislelizumab for Endometrial Cancer

Phase < 1
Waitlist Available
Led By Floor Backes, MD
Research Sponsored by Floor Backes
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This study is evaluating whether a monoclonal antibody may help treat patients with mismatch repair deficient endometrial cancer.

Eligible Conditions
  • Endometrial Cancer
  • Lynch Syndrome
  • Endometrial Adenocarcinoma
  • Uterine Carcinosarcoma

Timeline

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

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
T-cell receptor (TCR) clonality
T-cell receptor (TCR) diversity
T-cell receptor (TCR) profiles
Secondary outcome measures
Incidence of adverse events
Overall response rate (objective response rate complete response [CR] and partial response [PR]; clinical benefit rate CR + PR + stable)
Overall survival
+3 more

Side effects data

From 2022 Phase 3 trial • 512 Patients • NCT03430843
31%
Anaemia
24%
Weight decreased
17%
Cough
16%
Decreased appetite
16%
Constipation
16%
Pyrexia
15%
Aspartate aminotransferase increased
15%
Nausea
14%
Hypoalbuminaemia
13%
Fatigue
13%
Alanine aminotransferase increased
13%
Diarrhoea
12%
Hypothyroidism
12%
Hyponatraemia
11%
Asthenia
11%
Vomiting
11%
Pneumonia
11%
Back pain
10%
Pruritus
10%
Dyspnoea
9%
Dysphagia
9%
Arthralgia
9%
Hypokalaemia
9%
Rash
8%
Insomnia
7%
Hyperglycaemia
7%
Abdominal pain
7%
Blood alkaline phosphatase increased
7%
Productive cough
6%
Malaise
5%
Hypertension
5%
Hypoproteinaemia
5%
White blood cell count increased
5%
Gastrooesophageal reflux disease
5%
Gamma-glutamyltransferase increased
5%
Lymphocyte count decreased
5%
Platelet count decreased
4%
Abdominal pain upper
4%
Nasopharyngitis
4%
Cancer pain
4%
Leukopenia
4%
Hypotension
4%
Haemoptysis
4%
Stomatitis
4%
Blood creatine phosphokinase increased
4%
Oedema peripheral
4%
Blood creatine phosphokinase MB increased
4%
Abdominal distension
4%
Dizziness
4%
Blood bilirubin increased
4%
White blood cell count decreased
4%
Pneumonitis
3%
Hypocalcaemia
3%
Myalgia
3%
Hypoglycaemia
3%
Dysphonia
3%
Upper respiratory tract infection
3%
Hyperthyroidism
3%
C-reactive protein increased
3%
Hyperkalaemia
2%
Upper gastrointestinal haemorrhage
2%
Oesophageal obstruction
2%
Neutrophil count decreased
2%
Hyperuricaemia
2%
Hypochloraemia
2%
Thrombocytopenia
1%
Oesophageal fistula
1%
General physical health deterioration
1%
Multiple organ dysfunction syndrome
1%
Peripheral sensory neuropathy
1%
Sepsis
1%
Tumour pain
1%
Pleural effusion
1%
Oesophageal stenosis
1%
Oesophagomediastinal fistula
1%
Hypercalcaemia
1%
Pneumonia aspiration
1%
Type 1 diabetes mellitus
1%
Immune-mediated myositis
1%
Immune-mediated lung disease
1%
Pulmonary embolism
1%
Pulmonary haemorrhage
1%
Neutropenia
1%
Death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tislelizumab
Investigator Chosen Chemotherapy (ICC)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (tislelizumab)Experimental Treatment4 Interventions
Chemo naïve patients receive tislelizumab IV over 30-60 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Beginning cycle 4, patients who are chemotherapy naive with progressive disease, stable disease, or partial response, also receive carboplatin IV and paclitaxel IV every 21 days per standard of care for 6-9 cycles at the discretion of the treating physician. Patients who have received prior chemotherapy will receive single agent tislelizumab IV over 30-60 minutes on day 1. Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
2018
Completed Phase 3
~4260
Carboplatin
2014
Completed Phase 3
~6670
Biopsy
2014
Completed Phase 4
~850
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

Floor BackesLead Sponsor
2 Previous Clinical Trials
64 Total Patients Enrolled
Floor Backes, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
5 Previous Clinical Trials
338 Total Patients Enrolled
1 Trials studying Endometrial Cancer
204 Patients Enrolled for Endometrial Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Tislelizumab for the Treatment of Recurrent Mismatch Repair Deficient Endometrial Cancer
Floor Backes 2021. "Tislelizumab for the Treatment of Recurrent Mismatch Repair Deficient Endometrial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04906382.
~1 spots leftby Apr 2025
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