Trial Outcomes & Findings for Lenvatinib Plus Pembrolizumab In Patients With Immune Checkpoint Inhibitor Naïve Metastatic Uveal Melanoma (NCT NCT05308901)
NCT ID: NCT05308901
Last Updated: 2025-07-25
Results Overview
Progression free survival, defined as the time from enrollment to the first documented evidence of disease progression or death.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
An average of 6 months and 7 days from the time of enrollment.
Results posted on
2025-07-25
Participant Flow
Participant milestones
| Measure |
Pembrolizumab + Lenvatinib
Lenvatinib 20 mg daily plus pembrolizumab 200 mg IV every 3 weeks.
Pembrolizumab: 200 mg IV every 3 weeks for a maximum of 2 years.
Lenvatinib: 20 mg daily for a maximum of 2 years.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Pembrolizumab + Lenvatinib
Lenvatinib 20 mg daily plus pembrolizumab 200 mg IV every 3 weeks.
Pembrolizumab: 200 mg IV every 3 weeks for a maximum of 2 years.
Lenvatinib: 20 mg daily for a maximum of 2 years.
|
|---|---|
|
Overall Study
Death
|
6
|
Baseline Characteristics
Lenvatinib Plus Pembrolizumab In Patients With Immune Checkpoint Inhibitor Naïve Metastatic Uveal Melanoma
Baseline characteristics by cohort
| Measure |
Pembrolizumab + Lenvatinib
n=6 Participants
Lenvatinib 20 mg daily plus pembrolizumab 200 mg IV every 3 weeks.
Pembrolizumab: 200 mg IV every 3 weeks for a maximum of 2 years.
Lenvatinib: 20 mg daily for a maximum of 2 years.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
|
ECOG Performance Status
ECOG PS 0 (Asymptomatic)
|
6 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG PS 1 (Symptomatic but completely ambulatory)
|
0 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG PS 2 (Symptomatic, <50% in bed during the day)
|
0 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG PS 3 (Symptomatic, >50% in bed, but not bedbound)
|
0 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG PS 4 (Bedbound)
|
0 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG PS 5 (Death)
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: An average of 6 months and 7 days from the time of enrollment.Progression free survival, defined as the time from enrollment to the first documented evidence of disease progression or death.
Outcome measures
| Measure |
Pembrolizumab + Lenvatinib
n=6 Participants
Lenvatinib 20 mg daily plus pembrolizumab 200 mg IV every 3 weeks.
Pembrolizumab: 200 mg IV every 3 weeks for a maximum of 2 years.
Lenvatinib: 20 mg daily for a maximum of 2 years.
|
|---|---|
|
Evaluate the Effect of Lenvatinib Plus Pembrolizumab on Progression Free Survival
|
165 days
Interval 63.0 to 504.0
|
SECONDARY outcome
Timeframe: 6 weeks after treatment discontinuationPopulation: Tumor assessments were not completed for 2 patients after treatment discontinuation due to disease progression.
Objective response rate (complete and partial responses assessed by iRECIST)
Outcome measures
| Measure |
Pembrolizumab + Lenvatinib
n=4 Participants
Lenvatinib 20 mg daily plus pembrolizumab 200 mg IV every 3 weeks.
Pembrolizumab: 200 mg IV every 3 weeks for a maximum of 2 years.
Lenvatinib: 20 mg daily for a maximum of 2 years.
|
|---|---|
|
Evaluate the Objective Response Rate Resulting From Treatment With Lenvatinib Plus Pembrolizumab
iCR (Complete Response)
|
0 Participants
|
|
Evaluate the Objective Response Rate Resulting From Treatment With Lenvatinib Plus Pembrolizumab
iPR (Partial Response)
|
0 Participants
|
|
Evaluate the Objective Response Rate Resulting From Treatment With Lenvatinib Plus Pembrolizumab
iSD (Stable Disease)
|
3 Participants
|
|
Evaluate the Objective Response Rate Resulting From Treatment With Lenvatinib Plus Pembrolizumab
iUPD (Unconfirmed Progression)
|
1 Participants
|
|
Evaluate the Objective Response Rate Resulting From Treatment With Lenvatinib Plus Pembrolizumab
iCPD (Confirmed Progression)
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeks post treatment discontinuationOverall survival, defined as the time from enrollment to death (resulting from any cause).
Outcome measures
| Measure |
Pembrolizumab + Lenvatinib
n=6 Participants
Lenvatinib 20 mg daily plus pembrolizumab 200 mg IV every 3 weeks.
Pembrolizumab: 200 mg IV every 3 weeks for a maximum of 2 years.
Lenvatinib: 20 mg daily for a maximum of 2 years.
|
|---|---|
|
Evaluate the Effect of Treatment With Lenvatinib Plus Pembrolizumab on Overall Survival
|
287 Days
Interval 75.0 to 758.0
|
SECONDARY outcome
Timeframe: 30 days after last treatment dose, on average 5 months from the start of treatment.Number of participants who experienced dose reduction or treatment discontinuation due to treatment related adverse events (TRAE).
Outcome measures
| Measure |
Pembrolizumab + Lenvatinib
n=6 Participants
Lenvatinib 20 mg daily plus pembrolizumab 200 mg IV every 3 weeks.
Pembrolizumab: 200 mg IV every 3 weeks for a maximum of 2 years.
Lenvatinib: 20 mg daily for a maximum of 2 years.
|
|---|---|
|
Evaluate the Safety and Tolerability of Treatment With Lenvatinib Plus Pembrolizumab in Patients With Metastatic Uveal Melanoma
|
0 Participants
|
Adverse Events
Pembrolizumab + Lenvatinib
Serious events: 2 serious events
Other events: 6 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Pembrolizumab + Lenvatinib
n=6 participants at risk
Lenvatinib 20 mg daily plus pembrolizumab 200 mg IV every 3 weeks.
Pembrolizumab: 200 mg IV every 3 weeks for a maximum of 2 years.
Lenvatinib: 20 mg daily for a maximum of 2 years.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Hepatobiliary disorders
Hepatic Hemorrhage
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
Other adverse events
| Measure |
Pembrolizumab + Lenvatinib
n=6 participants at risk
Lenvatinib 20 mg daily plus pembrolizumab 200 mg IV every 3 weeks.
Pembrolizumab: 200 mg IV every 3 weeks for a maximum of 2 years.
Lenvatinib: 20 mg daily for a maximum of 2 years.
|
|---|---|
|
Gastrointestinal disorders
Abdominal cramping
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Gastrointestinal disorders
Abdominal pain
|
66.7%
4/6 • Number of events 9 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Investigations
Alanine aminotransferase increase
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
3/6 • Number of events 4 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
6/6 • Number of events 11 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Gastrointestinal disorders
Bloating
|
16.7%
1/6 • Number of events 3 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Cardiac disorders
Bradycardia
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Injury, poisoning and procedural complications
Bruising
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Investigations
BUN increased
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Bursitis, L Knee
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Skin and subcutaneous tissue disorders
Callous
|
16.7%
1/6 • Number of events 2 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
General disorders
Cold like symptoms
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Psychiatric disorders
Confusion
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6 • Number of events 3 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Renal and urinary disorders
Cystitis noninfective
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Gastrointestinal disorders
Dental caries
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Gastrointestinal disorders
Dermatitis, rectum
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 6 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Gastrointestinal disorders
Displaced tooth
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Nervous system disorders
Dysarthria
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Nervous system disorders
Dysgeusia
|
50.0%
3/6 • Number of events 4 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
2/6 • Number of events 2 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
2/6 • Number of events 2 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Gastrointestinal disorders
Early satiety
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
General disorders
Edema, limbs
|
50.0%
3/6 • Number of events 4 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
2/6 • Number of events 2 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme, bilateral ankles
|
16.7%
1/6 • Number of events 3 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
General disorders
Fatigue
|
83.3%
5/6 • Number of events 10 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Injury, poisoning and procedural complications
Fracture, tooth
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Reproductive system and breast disorders
Genital edema
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Gout, L big Toe
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
33.3%
2/6 • Number of events 2 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
2/6 • Number of events 2 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Vascular disorders
Hypertension
|
66.7%
4/6 • Number of events 6 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • Number of events 2 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Immune mediated arthritis
|
16.7%
1/6 • Number of events 3 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Psychiatric disorders
Insomnia
|
50.0%
3/6 • Number of events 3 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Skin and subcutaneous tissue disorders
Maculo-papular rash, left knee
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Psychiatric disorders
Mental fog
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
2/6 • Number of events 4 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Gastrointestinal disorders
Nausea
|
83.3%
5/6 • Number of events 6 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm, benign- Dentigerous cyst, R maxilla
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
General disorders
Non-cardiac chest pain
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
50.0%
3/6 • Number of events 3 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Gastrointestinal disorders
Oral sensitivity
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Skin and subcutaneous tissue disorders
Pain of skin (tender/sensitive)
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Skin and subcutaneous tissue disorders
Phytophotodermatitis
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
2/6 • Number of events 3 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Renal and urinary disorders
Pyuria
|
33.3%
2/6 • Number of events 3 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Eye disorders
Retinal ischemia
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Injury, poisoning and procedural complications
Right Medial Meniscus Tear
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Cardiac disorders
Sinus Tachycardia
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Gastrointestinal disorders
Stomach pain
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Gastrointestinal disorders
Tooth pain
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
2/6 • Number of events 2 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Nervous system disorders
Vasovagal Syncope
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
16.7%
1/6 • Number of events 1 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
|
Investigations
Weight Loss
|
33.3%
2/6 • Number of events 6 • 2 years
Adverse events were collected during each visit and at end of treatment visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place