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Monoclonal Antibodies

Pembrolizumab Combo 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

Has histologically or cytologically confirmed melanoma

Has not received more than 3 lines of therapy for their advanced melanoma

Must not have

Has had major surgery <3 weeks prior to first dose of study intervention

Has known history of hepatitis B

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 to see if they are more effective than the current options.

Who is the study for?

This trial is for adults with advanced melanoma that has worsened despite treatment with PD-1 inhibitors. Participants must have adequate organ function, not be pregnant or breastfeeding, and agree to use contraception if necessary. They should not have had more than three prior treatments for their melanoma and must have recovered from the major side effects of previous therapies.

What is being tested?

The study tests the safety and effectiveness of combining Pembrolizumab with other investigational drugs (Lenvatinib, ATRA, Quavonlimab, Vibostolimab) in treating melanoma resistant to standard PD-1 inhibitor therapy. It aims to find better options than current treatments by comparing different drug combinations.

What are the potential side effects?

Potential side effects may include immune system reactions affecting organs, infusion-related symptoms like fever or chills, fatigue, digestive issues such as nausea or diarrhea, skin reactions at injection sites, liver problems indicated by yellowing eyes or skin (jaundice), and an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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My melanoma diagnosis was confirmed through lab tests.

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I have had 3 or fewer treatments for my advanced melanoma.

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My melanoma cannot be removed with surgery and is in stage III or IV.

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My side effects from the last treatment are mild, except for hair loss.

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My cancer has grown despite treatment with specific immune therapy.

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My condition worsened despite treatment with an anti-PD-1/L1 drug.

Exclusion Criteria

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

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

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I have a history of hepatitis B.

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I have an autoimmune disease treated with medication in the last 2 years.

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

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My scans show cancer affecting major blood vessels or has caused holes in the tumor.

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I have received an organ or tissue transplant from another person.

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I have had active tuberculosis in the past.

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I am currently being treated for an infection.

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My melanoma is in the eye or on mucous membranes.

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I have a severe fistula.

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I have had lung inflammation not caused by an infection.

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My cancer has spread to my brain or spinal cord.

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)

Percentage of participants who discontinue study treatment due to an AE

Percentage of participants who experience an adverse event (AE)

Secondary study objectives

Duration of Response (DOR) per RECIST 1.1

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

3Treatment groups

Experimental Treatment

Group I: Pembrolizumab + all-trans retinoic acid (ATRA)Experimental Treatment1 Intervention

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

Group II: Pembrolizumab + Quavonlimab + VibostolimabExperimental Treatment3 Interventions

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

Group III: Pembrolizumab + Quavonlimab + LenvatinibExperimental Treatment3 Interventions

Participants will receive pembrolizumab IV plus quavonlimab 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

ATRA

1993

Completed Phase 4

~1250

Lenvatinib

2017

Completed Phase 4

~2070