← Back to Search

Other

Pembrolizumab + Other Agents 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 clinically detectable and resectable Stage IIIB or IIIC or IIID melanoma amenable to surgery

Must not have

Is not naïve to Talimogene laherparepvec (TVEC) and other oncolytic viruses

Has only mucosal lesions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing new treatments for melanoma, specifically to see if they are safe and more effective than current options.

Who is the study for?

This trial is for adults with Stage III melanoma suitable for pre-surgery (neoadjuvant) therapy. They must not be pregnant, breastfeeding, or planning to conceive; agree to use contraception; have good organ function; and no recent immunosuppressive treatments or active infections. Prior treatment for melanoma is limited to surgery or radiotherapy on the primary tumor.

What is being tested?

The study tests Pembrolizumab alone or combined with other agents (Vibostolimab, Gebasaxturev, MK-4830, Favezelimab, ATRA) in different groups of participants. The aim is to find which combination works better than current treatments by comparing safety and effectiveness before surgery.

What are the potential side effects?

Potential side effects include immune reactions that can affect organs like the liver and lungs, infusion-related reactions such as fever and chills, fatigue, skin rash, hormonal gland issues like thyroid dysfunction, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

Select...

My melanoma diagnosis was confirmed through lab tests.

Select...

My melanoma is at a stage where surgery is possible.

Select...

I am a male willing to use contraception or abstain from sex while on ATRA and for 7 days after.

Select...

I have not received treatment for my Stage IIIB, IIIC, or IIID melanoma.

Exclusion Criteria

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

Select...

I have previously been treated with TVEC or other virus-based cancer therapies.

Select...

My cancer is only present in the mucosal areas.

Select...

My cancer has spread to my brain or the membranes around my brain.

Select...

I have received a transplant from another person.

Select...

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

Select...

I am currently being treated for an infection.

Select...

I have a history of hepatitis B.

Select...

I have had pneumonitis that was not caused by an infection.

Select...

I have had active tuberculosis in the past.

Select...

My melanoma is in the eye or mucous membranes.

Select...

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

Select...

I have a known history of HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~60 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

Pathological complete response (pCR) rate

Percentage of participants who discontinue study treatment due to an AE

Percentage of participants who experience an adverse event (AE)

Secondary study objectives

Near pathological complete response (near pCR) rate

Pathological partial response (pPR) rate

Recurrence-free survival (RFS)

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

6Treatment groups

Experimental Treatment

Group I: Pembrolizumab + all-trans retinoic acid (ATRA)Experimental Treatment2 Interventions

Prior to tumor resection surgery, in the neoadjuvant phase, participants will receive pembrolizumab IV plus ATRA orally at specified doses on specified days. After surgery, in the adjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. Participants will receive treatments in the neoadjuvant and adjuvant phase for a total treatment duration of up to approximately 1 year.

Group II: Pembrolizumab + VibostolimabExperimental Treatment2 Interventions

Prior to tumor resection surgery, in the neoadjuvant phase, participants will receive pembrolizumab intravenously (IV) plus vibostolimab IV at specified doses on specified days. After surgery, in the adjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. Participants will receive treatments in the neoadjuvant and adjuvant phase for a total treatment duration of up to approximately 1 year.

Group III: Pembrolizumab + MK-4830Experimental Treatment2 Interventions

Prior to tumor resection surgery, in the neoadjuvant phase, participants will receive pembrolizumab IV plus MK-4830 IV at specified doses on specified days. After surgery, in the adjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. Participants will receive treatments in the neoadjuvant and adjuvant phase for a total treatment duration of up to approximately 1 year.

Group IV: Pembrolizumab + GebasaxturevExperimental Treatment2 Interventions

Prior to tumor resection surgery, in the neoadjuvant phase, participants will receive pembrolizumab IV plus gebasaxturev (V937) intratumorally (IT) at specified doses on specified days. After surgery, in the adjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. Participants will receive treatments in the neoadjuvant and adjuvant phase for a total treatment duration of up to approximately 1 year.

Group V: PembrolizumabExperimental Treatment1 Intervention

Prior to tumor resection surgery, in the neoadjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. After surgery, in the adjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. Participants will receive treatments in the neoadjuvant and adjuvant phase for a total treatment duration of up to approximately 1 year.

Group VI: Favezelimab + PembrolizumabExperimental Treatment1 Intervention

Prior to tumor resection surgery, in the neoadjuvant phase, participants will receive MK-4280A (favezelimab and pembrolizumab administered as a co-formulation) IV at specified doses on specified days. After surgery, in the adjuvant phase, participants will receive pembrolizumab IV at a specified dose on specified days. Participants will receive treatments in the neoadjuvant and adjuvant phase for a total treatment duration of up to approximately 1 year.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MK-4830

2022

Completed Phase 2

~160

ATRA

1993

Completed Phase 4

~1250