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Tyrosine Kinase Inhibitor

Pembrolizumab Combinations for Melanoma

Phase 1 & 2

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

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

Must have

Female participants agree to abstain from breastfeeding during the study intervention period

Has American Joint Committee on Cancer (AJCC) Stage IV, M1D melanoma

Must not have

Has untreated or unresolved intracranial hemorrhage from central nervous system (CNS) metastasis

Has a history of (noninfectious) pneumonitis that required steroids or current pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing experimental treatments for melanoma, a type of skin cancer. The goal is to find treatments that are safe and more effective than what is currently available.

Who is the study for?

This trial is for adults with Stage IV melanoma that has spread to the brain, who haven't used steroids recently and aren't pregnant or breastfeeding. They must have good organ function and agree to use contraception. People with weakened immune systems, recent surgeries or therapies, active infections, other cancers within 2 years, or certain viral diseases can't join.

What is being tested?

The study tests Pembrolizumab alone or combined with Quavonlimab in treating melanoma in the brain. The combination of Pembrolizumab and Lenvatinib was part of the study but is no longer being tested as of December 2022.

What are the potential side effects?

Pembrolizumab may cause immune system reactions affecting organs, fatigue, skin issues, flu-like symptoms; Quavonlimab's side effects are under investigation but could be similar due to its nature as an immunotherapy agent.

Eligibility Criteria

Inclusion Criteria

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

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I agree not to breastfeed during the study.

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My melanoma is at the most advanced stage, having spread to distant parts of my body.

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I am not pregnant or breastfeeding and follow the required contraceptive guidelines.

Exclusion Criteria

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

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I have untreated bleeding in my brain from cancer spread.

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I have had pneumonitis treated with steroids or have it now.

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I have been treated for an autoimmune disease in the last 2 years.

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My cancer has spread to the lining of my brain and spinal cord.

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I have undergone whole brain irradiation.

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I have another cancer that is getting worse or needed treatment in the last 2 years.

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I have a known history of HIV.

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I have a history of hepatitis B or C.

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I have been diagnosed with eye melanoma.

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I have not had major surgery in the last 3 weeks.

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I have not received a live vaccine in the last 30 days.

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I have received a transplant from another person.

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I am currently being treated for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)

Therapeutic procedure

Percentage of participants who experience an adverse event (AE)

Secondary study objectives

Brain

Duration of Response (DOR) per RECIST 1.1

+1 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Pembrolizumab + LenvatinibExperimental Treatment2 Interventions

Participants will receive pembrolizumab IV plus lenvatinib orally at specified doses on specified days for a total treatment duration of up to approximately 2 years.

Group II: Coformulation Pembrolizumab/Quavonlimab + LenvatinibExperimental Treatment3 Interventions

Participants will receive pembrolizumab/quavonlimab (coformulation of pembrolizumab and quavonlimab) intravenously (IV) plus lenvatinib orally at specified doses on specified days for a total treatment duration of up to approximately 2 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Pembrolizumab/Quavonlimab

2017

Completed Phase 2

~420