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PD-1 Inhibitor

Retifanlimab for Merkel Cell Carcinoma

Phase 2
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group performance status of 0 to 1
Diagnosis of MCC with distant metastatic disease or recurrent, advanced locoregional disease not amenable to surgery or radiation
Must not have
Current use of protocol-defined prohibited medication
Active bacterial, fungal, or viral infections, including hepatitis A, B, and C
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 33.9 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new medication called INCMGA00012, which helps the immune system fight cancer. It is aimed at patients with advanced or metastatic Merkel cell carcinoma, a severe form of skin cancer that has spread. The medication works by boosting the immune system to better identify and destroy cancer cells.

Who is the study for?
This trial is for adults with advanced Merkel Cell Carcinoma (MCC) that has spread or can't be treated with surgery/radiation. Participants should be relatively healthy, able to provide a tumor sample, and not planning to conceive. Those who've had recent cancer treatments or certain other medical conditions are excluded.
What is being tested?
The study is evaluating the effectiveness and safety of a drug called INCMGA00012 (Retifanlimab) in treating MCC. It will involve monitoring participants' responses to the medication and any changes in their disease according to specific criteria.
What are the potential side effects?
While not explicitly listed here, similar drugs often cause immune-related reactions affecting various organs, infusion-related symptoms, fatigue, skin issues, gastrointestinal discomforts, potential infections due to lowered immunity among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can carry out all my usual activities without help.
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My Merkel cell carcinoma has spread or returned and cannot be treated with surgery or radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking any medications that are not allowed in this study.
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I do not have any active infections, including hepatitis.
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I have received treatments like chemotherapy or PD-1/PD-L1 therapy for Merkel Cell Carcinoma.
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My cancer has spread to my brain or the coverings of my brain.
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I haven't had radiation therapy in the last 2 weeks or high-dose chest radiation in the last 6 months.
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I do not have serious lung, heart, stomach, or autoimmune diseases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 33.9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 33.9 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)
Secondary study objectives
Disease Control Rate (DCR)
Duration of Response (DOR)
First-dose AUC0-t of Retifanlimab
+5 more

Side effects data

From 2021 Phase 2 trial • 94 Patients • NCT03597295
23%
Asthenia
21%
Diarrhoea
18%
Fatigue
16%
Nausea
16%
Anaemia
15%
Vomiting
13%
Constipation
13%
Decreased appetite
12%
Pruritus
12%
Cough
12%
Dyspnoea
11%
Pyrexia
10%
Hypothyroidism
10%
Rectal haemorrhage
9%
Arthralgia
9%
Back pain
9%
Headache
9%
Weight decreased
7%
Urinary tract infection
7%
Proctalgia
7%
Aspartate aminotransferase increased
7%
Abdominal pain
6%
Insomnia
5%
Hypokalaemia
5%
Rash
5%
Cystitis
3%
General physical health deterioration
3%
Pelvic pain
2%
Hypercalcaemia
2%
Inadequate analgesia
2%
Intestinal obstruction
2%
Haematuria
2%
Pleural effusion
2%
Sepsis
2%
Pneumonia
1%
Mental status changes
1%
Pseudomonas infection
1%
Purpura
1%
Respiratory failure
1%
Proctitis haemorrhagic
1%
Acute kidney injury
1%
Anal abscess
1%
Gastroenteritis
1%
Interstitial lung disease
1%
Pancreatic carcinoma
1%
Adrenal insufficiency
1%
Hydronephrosis
1%
Ileus
1%
Flank pain
1%
Immune-mediated enterocolitis
1%
Large intestinal obstruction
1%
Pain
1%
Acute respiratory failure
1%
Cholecystitis acute
1%
Lyme disease
1%
Lymphangiosis carcinomatosa
1%
Herpes zoster
1%
Hepatitis
1%
Pelvic infection
1%
Peritonitis
1%
Blood bilirubin increased
1%
Body temperature increased
1%
Bone pain
1%
Cellulitis
1%
Cholangitis
1%
Cholecystitis
1%
Cognitive disorder
1%
Colonic fistula
1%
Coma hepatic
1%
Dehydration
1%
Device related infection
1%
Diffuse large B-cell lymphoma
1%
Fall
1%
Femur fracture
1%
Gastric ulcer
1%
Skin infection
1%
Stoma site infection
1%
Superior mesenteric artery syndrome
1%
Thrombosis
1%
Transitional cell carcinoma
1%
Tumour embolism
1%
Tumour pain
1%
Ureteric compression
1%
Urinary retention
1%
Venous thrombosis limb
1%
Pulmonary embolism
1%
Catheter site pain
1%
Pneumocystis jirovecii pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Retifanlimab 500 mg

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: Retifanlimab: Chemotherapy: RefractoryExperimental Treatment1 Intervention
Group II: Retifanlimab: Chemotherapy: NaïveExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Retifanlimab
2018
Completed Phase 2
~430

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Merkel Cell Carcinoma (MCC) include immune checkpoint inhibitors such as anti-PD-1 monoclonal antibodies (e.g., pembrolizumab, nivolumab, and avelumab). These therapies work by blocking the programmed cell death protein 1 (PD-1) pathway, which cancer cells exploit to evade the immune system. By inhibiting this pathway, these drugs enhance the body's immune response against cancer cells, leading to improved tumor control and potentially durable responses. This mechanism is particularly important for MCC patients because MCC is an aggressive skin cancer with a high likelihood of metastasis, and traditional chemotherapy often has limited efficacy and significant side effects. Immune checkpoint inhibitors offer a more targeted approach with the potential for long-term remission.
The State of Immune Checkpoint Inhibition in Urothelial Carcinoma: Current Evidence and Future Areas of Exploration.The presentation, pathology, and current management strategies of cutaneous metastasis.

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
392 Previous Clinical Trials
63,834 Total Patients Enrolled
Incyte Medical MonitorStudy DirectorIncyte Corporation
34 Previous Clinical Trials
12,018 Total Patients Enrolled

Media Library

Retifanlimab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03599713 — Phase 2
Merkel Cell Carcinoma Research Study Groups: Retifanlimab: Chemotherapy: Naïve, Retifanlimab: Chemotherapy: Refractory
Merkel Cell Carcinoma Clinical Trial 2023: Retifanlimab Highlights & Side Effects. Trial Name: NCT03599713 — Phase 2
Retifanlimab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03599713 — Phase 2
~16 spots leftby Dec 2025