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Pembrolizumab Combinations for Melanoma

Phase 1 & 2

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

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

Must have

Has been untreated for advanced disease

Has been untreated for advanced disease.

Must not have

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

Has history of Hepatitis B or known Hepatitis C virus infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing new treatments for melanoma, a type of skin cancer, to see if they are safe and effective. The goal is to find treatments that are better than the current options.

Who is the study for?

This trial is for adults with advanced melanoma (Stage III or IV) that can't be removed by surgery and haven't been treated yet. They must have good organ function, not be pregnant or breastfeeding, agree to use contraception if applicable, and have recovered from previous treatments' side effects. People with immune deficiencies, other active cancers, brain metastases, hepatitis B/C, recent major surgeries or vaccines, certain mental disorders or infections are excluded.

What is being tested?

The study tests the safety and effectiveness of Pembrolizumab alone or combined with experimental drugs like Vibostolimab and Lenvatinib in treating first-line advanced melanoma. Participants are divided into different groups receiving various combinations of these medications to find the best treatment option.

What are the potential side effects?

Potential side effects may include immune-related reactions affecting organs; infusion-related symptoms; fatigue; skin changes; hormonal gland issues leading to hormone imbalances; liver inflammation; digestive problems such as colitis; lung issues like pneumonitis.

Eligibility Criteria

Inclusion Criteria

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

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I have not received treatment for my advanced disease.

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I have not received treatment for my advanced disease.

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My melanoma diagnosis was confirmed through lab tests.

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

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 in the last 3 weeks.

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I have had Hepatitis B or have Hepatitis C.

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I had radiotherapy less than 2 weeks before starting the study treatment.

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

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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 the membranes around my brain.

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I have received a transplant from another person.

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I have had active tuberculosis in the past.

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 discontinue study treatment due to an AE: Safety lead-in

+3 more

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

Clostridium difficile colitis

Systemic infection

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

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group

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

Trial Design

7Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab + VibostolimabExperimental Treatment2 Interventions

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

Group III: Coformulation Pembrolizumab/QuavonlimabExperimental Treatment2 Interventions

Participants will receive coformulation of pembrolizumab and quavonlimab (MK-1308A) IV at a specified dose on specified days for a total treatment duration of up to approximately 2 years.

Group IV: Coformulation Favezelimab/Pembrolizumab + VibostolimabExperimental Treatment2 Interventions

Participants will receive coformulation of favezelimab and pembrolizumab (MK-4280A) IV and vibostolimab IV at specified doses on specified days for a total treatment duration of up to approximately 2 years.

Group V: Coformulation Favezelimab/Pembrolizumab + All-trans Retinoic Acid (ATRA)Experimental Treatment1 Intervention

Participants will receive coformulation of favezelimab and pembrolizumab IV Q3W for up to 35 cycles, plus ATRA orally (for 3 days surrounding each infusion of MK-4280A, including Days 1, 2, and 3 of Cycle 1 and on Days -1, 1, and 2 of all subsequent cycles).

Group VI: Coformulation Favezelimab/PembrolizumabExperimental Treatment1 Intervention

Participants will receive cofomulation of favezelimab + pembrolizumab (MK-4280A) IV at specified dose on specified days every 3 weeks (Q3W) for up to approximately 2 years

Group VII: PembrolizumabActive Control1 Intervention

Participants will receive pembrolizumab IV at a specified dose 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

Favezelimab/Pembrolizumab

2016

Completed Phase 1

~490

ATRA

1993