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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 33.9 months
Awards & highlights

Study Summary

This trial is testing a new drug for people with advanced Merkel cell cancer. The goal is to see if it is safe and if it works.

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.Check my eligibility
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.See study design
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
Select...
I can carry out all my usual activities without help.
Select...
My Merkel cell carcinoma has spread or returned and cannot be treated with surgery or radiation.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
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%
Inadequate analgesia
2%
Intestinal obstruction
2%
Hypercalcaemia
2%
Haematuria
2%
Pleural effusion
2%
Sepsis
2%
Pneumonia
1%
Purpura
1%
Acute kidney injury
1%
Flank pain
1%
Large intestinal obstruction
1%
Hydronephrosis
1%
Adrenal insufficiency
1%
Gastroenteritis
1%
Pancreatic carcinoma
1%
Respiratory failure
1%
Pain
1%
Proctitis haemorrhagic
1%
Immune-mediated enterocolitis
1%
Interstitial lung disease
1%
Mental status changes
1%
Pseudomonas infection
1%
Anal abscess
1%
Ileus
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

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
~320

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
364 Previous Clinical Trials
55,058 Total Patients Enrolled
Incyte Medical MonitorStudy DirectorIncyte Corporation
22 Previous Clinical Trials
4,941 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Retifanlimab acquired regulatory clearance from the FDA?

"Our assessment of the safety profile for Retifanlimab was a 2, as there is evidence to suggest it is safe but no clinical trials that support its efficacy."

Answered by AI

What prior investigations have been conducted concerning Retifanlimab?

"As of now, 26 active trials are exploring the efficacy of Retifanlimab with 3 in Phase 3. While A CORU�A and Virginia have a significant concentration of studies, 810 sites across the world are running these tests."

Answered by AI

Is this the inaugural trial for such a protocol?

"Since its initial study, conducted in 2016 and sponsored by Incyte Corporation, retifanlimab has undergone extensive testing. After being granted Phase 1 approval following the first trial involving 325 patients, there are currently 26 active studies for this drug across 117 cities in 43 nations."

Answered by AI

What objectives are the researchers hoping to achieve with this investigation?

"This clinical trial aims to assess the Objective Response Rate of chemotherapy-naive patients with advanced/metastatic MCC using RECIST v1.1, as Determined by independent Central Radiographic Review (ICR), over a period extending from Baseline up to approximately 8 months. Other metrics that are being evaluated include Disease Control Rate, tmax of INCMGA00012, and Cmax of INCMGA00012."

Answered by AI

How many healthcare facilities are currently administering this clinical trial?

"Numerous medical centres are engaging in the recruitment of patients for this study, including Norton Cancer Institute (Louisville), Stanford Cancer Institute (Palo Alto), and McGill University Health Centre/Glen Site/Cedars Cancer Centre (Montreal). Additionally, 16 other sites have also signed on."

Answered by AI

Are additional volunteers being welcomed into this medical experiment?

"As indicated on clinicaltrials.gov, this particular medical study is no longer actively enrolling patients. However, there are currently 2503 other trials which require participants and can be accessed from the same website. The trial was initially posted on February 25th 2019, but has since been closed off to new candidates as of September 29th 2022."

Answered by AI

How many individuals are currently enrolled in this clinical research?

"This research endeavour is now closed for recruitment. It was first announced on February 25th 2019, with the last update made on September 29th 2022. For other trials related to carcinoma or merkel cell, 2477 are available; alternatively 26 studies recruiting participants for Retifanlimab are currently active."

Answered by AI
~18 spots leftby Apr 2025