What side effects are associated with this type of intervention?

Treatments for Merkel Cell Carcinoma, particularly those involving Anti-PD-1 Monoclonal Antibodies like INCMGA00012, commonly cause immune-related adverse events. These include fatigue, rash, diarrhea, and pruritus. Less common but more severe side effects can include pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis, due to the immune system attacking normal organs and tissues.

What prior FDA approvals exist?

The FDA has previously approved avelumab, an anti-PD-L1 monoclonal antibody, for the treatment of metastatic Merkel Cell Carcinoma. Avelumab was the first immunotherapy approved for MCC and has shown efficacy in treating this aggressive skin cancer. Additionally, pembrolizumab, another anti-PD-1 monoclonal antibody, has also been approved for MCC, providing another immunotherapy option for patients with this condition.

What other types of research exist?

Promising novel alternatives to INCMGA00012 for Merkel Cell Carcinoma patients include pembrolizumab and cemiplimab, both of which are anti-PD-1 therapies with demonstrated efficacy in treating other skin cancers. Additionally, ongoing studies of new biotherapies and immune checkpoint inhibitors may offer further options.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 33.9 months

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

Arthralgia

Back pain

Headache

Weight decreased

Urinary tract infection

Proctalgia

Aspartate aminotransferase increased

Abdominal pain

Insomnia

Hypokalaemia

Rash

Cystitis

General physical health deterioration

Pelvic pain

Hypercalcaemia

Inadequate analgesia

Intestinal obstruction

Haematuria

Pleural effusion

Sepsis

Pneumonia

Proctitis haemorrhagic

Respiratory failure

Pseudomonas infection

Purpura

Mental status changes

Acute kidney injury

Anal abscess

Gastroenteritis

Interstitial lung disease

Pancreatic carcinoma

Adrenal insufficiency

Hydronephrosis

Ileus

Flank pain

Immune-mediated enterocolitis

Large intestinal obstruction

Pain

Acute respiratory failure

Cholecystitis acute

Lyme disease

Lymphangiosis carcinomatosa

Herpes zoster

Hepatitis

Pelvic infection

Peritonitis

Blood bilirubin increased

Body temperature increased

Bone pain

Cellulitis

Cholangitis

Cholecystitis

Cognitive disorder

Colonic fistula

Coma hepatic

Dehydration

Device related infection

Diffuse large B-cell lymphoma

Fall

Femur fracture

Gastric ulcer

Skin infection

Stoma site infection

Superior mesenteric artery syndrome

Thrombosis

Transitional cell carcinoma

Tumour embolism

Tumour pain

Ureteric compression

Urinary retention

Venous thrombosis limb

Pulmonary embolism

Catheter site pain

Pneumocystis jirovecii pneumonia

100%

80%

60%

40%

20%

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

0 / 8Eligibility criteria met

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.

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