Trial Outcomes & Findings for Sitravatinib and Tislelizumab in Patients With Metastatic Uveal Melanoma With Liver Metastases. (NCT NCT05542342)
NCT ID: NCT05542342
Last Updated: 2026-06-01
Results Overview
ORR is defined as the proportion of patients with at least one complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Throughout the study period, approximately 1 year per patient
Results posted on
2026-06-01
Participant Flow
Participant milestones
| Measure |
Experimental Arm
Patients will receive sitravatinib 100 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks until progression of disease, unacceptable toxicity, death, or consent withdrawal, whichever occurs first. Treatment may be continued after progression according to physician criteria (with previous consultation with Coordinating investigator) until patients no longer receive clinical benefit.
Tislelizumab: 200 mg IV once every 3 weeks
Sitravatinib Malate: 100 mg orally once daily
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The information is not available fro 2 patients
Baseline characteristics by cohort
| Measure |
Experimental Arm
n=16 Participants
Patients will receive Sitravatinib 100 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks until progression of disease, unacceptable toxicity, death, or consent withdrawal, whichever occurs first. Treatment may be continued after progression according to physician criteria (with previous consultation with Coordinating investigator) until patients no longer receive clinical benefit.
Tislelizumab: 200 mg IV once every 3 weeks
Sitravatinib Malate: 100 mg orally once daily
|
|---|---|
|
Age, Continuous
|
63 years
n=16 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=16 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
16 Participants
n=16 Participants
|
|
Region of Enrollment
Spain
|
16 participants
n=16 Participants
|
|
Weight
|
71 kg
n=16 Participants
|
|
Systolic Blood Pressure
|
134.5 mmHg
n=16 Participants
|
|
Diastolic Blood Pressure
|
79.5 mmHg
n=16 Participants
|
|
Temperature
|
36.3 ºC
n=16 Participants
|
|
Respiration rate
|
16 bpm
n=16 Participants
|
|
Height
|
164 cm
n=14 Participants • The information is not available fro 2 patients
|
|
Pulse rate
|
84 bpm
n=16 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
0
|
13 participants
n=16 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
1
|
3 participants
n=16 Participants
|
|
Physical exam
Normal
|
16 Participants
n=16 Participants
|
|
Physical exam
Abnormal
|
0 Participants
n=16 Participants
|
|
Tobacco Smoking History
Never smoker
|
7 Participants
n=16 Participants • Information not reported
|
|
Tobacco Smoking History
Former smoker
|
2 Participants
n=16 Participants • Information not reported
|
|
Tobacco Smoking History
Smoker
|
1 Participants
n=16 Participants • Information not reported
|
|
Tobacco Smoking History
Not available
|
6 Participants
n=16 Participants • Information not reported
|
|
Baseline lactate dehydrogenase (LDH)
Normal
|
7 Participants
n=16 Participants
|
|
Baseline lactate dehydrogenase (LDH)
Elevated
|
9 Participants
n=16 Participants
|
|
Baseline gamma-glutamyltransferase (GGT)
Normal
|
11 Participants
n=16 Participants • Missing data
|
|
Baseline gamma-glutamyltransferase (GGT)
Elevated
|
4 Participants
n=16 Participants • Missing data
|
|
Baseline gamma-glutamyltransferase (GGT)
Not available
|
1 Participants
n=16 Participants • Missing data
|
|
Baseline Alkaline Phosphatase
Normal
|
11 Participants
n=16 Participants
|
|
Baseline Alkaline Phosphatase
Elevated
|
5 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: Throughout the study period, approximately 1 year per patientORR is defined as the proportion of patients with at least one complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
Outcome measures
| Measure |
Experimental Arm
n=16 Participants
Patients will receive Sitravatinib 100 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks until progression of disease, unacceptable toxicity, death, or consent withdrawal, whichever occurs first. Treatment may be continued after progression according to physician criteria (with previous consultation with Coordinating investigator) until patients no longer receive clinical benefit.
Tislelizumab: 200 mg IV once every 3 weeks
Sitravatinib Malate: 100 mg orally once daily
|
|---|---|
|
Objective Response Rate (ORR)
|
3 Participants
|
SECONDARY outcome
Timeframe: Throughout the study period, approximately 1 year per patientFor this protocol, PFS is defined as the time from the first dose of study treatment until objective tumor progression according to RECIST 1.1 or death, whichever occurs first.
Outcome measures
| Measure |
Experimental Arm
n=16 Participants
Patients will receive Sitravatinib 100 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks until progression of disease, unacceptable toxicity, death, or consent withdrawal, whichever occurs first. Treatment may be continued after progression according to physician criteria (with previous consultation with Coordinating investigator) until patients no longer receive clinical benefit.
Tislelizumab: 200 mg IV once every 3 weeks
Sitravatinib Malate: 100 mg orally once daily
|
|---|---|
|
Progression-Free Survival (PFS)
|
7.7 months
Interval 5.6 to
The follow-up is not longer enough to calculate the upper interval.
|
SECONDARY outcome
Timeframe: Throughout the study period, approximately 1 year per patientOverall Survival is defined as the time from the first dose of study treatment until death from any cause. Those patients that do not present a death event or are lost to follow up will be censored at the date of the last contact.
Outcome measures
| Measure |
Experimental Arm
n=16 Participants
Patients will receive Sitravatinib 100 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks until progression of disease, unacceptable toxicity, death, or consent withdrawal, whichever occurs first. Treatment may be continued after progression according to physician criteria (with previous consultation with Coordinating investigator) until patients no longer receive clinical benefit.
Tislelizumab: 200 mg IV once every 3 weeks
Sitravatinib Malate: 100 mg orally once daily
|
|---|---|
|
Overall Survival (OS)
|
15.9 months
Interval 11.6 to
The follow-up is not longer enough to calculate the upper interval.
|
Adverse Events
Experimental Arm
Serious events: 8 serious events
Other events: 16 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Experimental Arm
n=16 participants at risk
Patients will receive Sitravatinib 100 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks until progression of disease, unacceptable toxicity, death, or consent withdrawal, whichever occurs first. Treatment may be continued after progression according to physician criteria (with previous consultation with Coordinating investigator) until patients no longer receive clinical benefit.
Tislelizumab: 200 mg IV once every 3 weeks
Sitravatinib Malate: 100 mg orally once daily
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.2%
1/16 • 32 months
|
|
Vascular disorders
Pulmonary embolism
|
6.2%
1/16 • 32 months
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • 32 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16 • 32 months
|
|
General disorders
Application site rash
|
6.2%
1/16 • 32 months
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
2/16 • 32 months
|
|
Vascular disorders
Septic shock
|
6.2%
1/16 • 32 months
|
|
Infections and infestations
Enterocolitis infectious
|
6.2%
1/16 • 32 months
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
6.2%
1/16 • 32 months
|
|
Nervous system disorders
Nervous system disorder
|
6.2%
1/16 • 32 months
|
|
General disorders
Disease progression
|
6.2%
1/16 • 32 months
|
Other adverse events
| Measure |
Experimental Arm
n=16 participants at risk
Patients will receive Sitravatinib 100 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks until progression of disease, unacceptable toxicity, death, or consent withdrawal, whichever occurs first. Treatment may be continued after progression according to physician criteria (with previous consultation with Coordinating investigator) until patients no longer receive clinical benefit.
Tislelizumab: 200 mg IV once every 3 weeks
Sitravatinib Malate: 100 mg orally once daily
|
|---|---|
|
General disorders
Asthenia
|
93.8%
15/16 • 32 months
|
|
Gastrointestinal disorders
Diarrhea
|
93.8%
15/16 • 32 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
68.8%
11/16 • 32 months
|
|
Vascular disorders
Hypertension
|
62.5%
10/16 • 32 months
|
|
Gastrointestinal disorders
Nausea
|
43.8%
7/16 • 32 months
|
|
Vascular disorders
Accelerated hypertension
|
43.8%
7/16 • 32 months
|
|
Investigations
Alanine aminotransferase increased
|
43.8%
7/16 • 32 months
|
|
Nervous system disorders
Dysphonia
|
37.5%
6/16 • 32 months
|
|
Nervous system disorders
Dysgeusia
|
37.5%
6/16 • 32 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
31.2%
5/16 • 32 months
|
|
Gastrointestinal disorders
Abdominal pain
|
31.2%
5/16 • 32 months
|
|
Investigations
Aspartate aminotransferase increased
|
31.2%
5/16 • 32 months
|
|
Investigations
Blood thyroid stimulating hormone increased
|
25.0%
4/16 • 32 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
4/16 • 32 months
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
4/16 • 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
25.0%
4/16 • 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
4/16 • 32 months
|
|
Metabolism and nutrition disorders
Hypothyroidism
|
25.0%
4/16 • 32 months
|
|
General disorders
Mucosal inflammation
|
18.8%
3/16 • 32 months
|
|
Gastrointestinal disorders
Constipation
|
18.8%
3/16 • 32 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.8%
3/16 • 32 months
|
|
Cardiac disorders
Chest pain
|
18.8%
3/16 • 32 months
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
18.8%
3/16 • 32 months
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • 32 months
|
|
General disorders
Pyrexia
|
12.5%
2/16 • 32 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
12.5%
2/16 • 32 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
12.5%
2/16 • 32 months
|
|
Cardiac disorders
Dizziness
|
12.5%
2/16 • 32 months
|
|
Investigations
Amylase increased
|
12.5%
2/16 • 32 months
|
|
Investigations
Lipase increased
|
12.5%
2/16 • 32 months
|
|
Vascular disorders
Gingival bleeding
|
12.5%
2/16 • 32 months
|
|
General disorders
Stomatitis
|
12.5%
2/16 • 32 months
|
|
General disorders
Haemorrhoids
|
12.5%
2/16 • 32 months
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
2/16 • 32 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.5%
2/16 • 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
2/16 • 32 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
2/16 • 32 months
|
|
Investigations
Weight decreased
|
12.5%
2/16 • 32 months
|
|
Psychiatric disorders
Insomnia
|
12.5%
2/16 • 32 months
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
12.5%
2/16 • 32 months
|
|
Investigations
SARS-CoV-2 test positive
|
12.5%
2/16 • 32 months
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
1/16 • 32 months
|
|
Eye disorders
Visual impairment
|
6.2%
1/16 • 32 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.2%
1/16 • 32 months
|
|
Investigations
SARS-CoV-2 antibody test
|
6.2%
1/16 • 32 months
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
1/16 • 32 months
|
|
Metabolism and nutrition disorders
Hyperthyroidism
|
6.2%
1/16 • 32 months
|
|
Gastrointestinal disorders
Aerophagia
|
6.2%
1/16 • 32 months
|
|
Cardiac disorders
Atrial tachycardia
|
6.2%
1/16 • 32 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.2%
1/16 • 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
6.2%
1/16 • 32 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
6.2%
1/16 • 32 months
|
|
Cardiac disorders
Atrial fibrillation
|
6.2%
1/16 • 32 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place