A Phase 2 Study of INCMGA00012 in Participants With Metastatic Merkel Cell Carcinoma

Phase 1

• Conditions: Metastatic Merkel cell carcinoma; MedDRA version: 21.1Level: LLTClassification code 10064025Term: Merkel cell carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-001627-39-GB
• Lead Sponsor: Incyte Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-30
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:
1. Signed informed consent.
2. Men and women, aged 18 or older (or as applicable per local country requirements).
3. Diagnosis of MCC with distant metastatic disease or recurrent,
advanced locoregional disease not amenable to surgery or radiation and no more than 3 prior systemic treatments, inclusive of systemic adjuvant therapy.
4. ECOG performance status of 0 to 1.
5. Measurable disease according to RECIST v1.1. Tumor lesions that are
located in a previously irradiated area or in an area subjected to other
locoregional therapy should only be selected as target lesions if
progression has been demonstrated in such lesions.
6. Availability of tumor tissue (fresh or archival) for central pathology review.
7. Willingness to avoid pregnancy or fathering children based on the criteria below:
a. Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through 6 months after the last dose of study treatment and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.
b. Women of childbearing potential must have a negative serum pregnancy test at screening and before the first dose on Day 1 and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.
c. Women of nonchildbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR = 12 months of amenorrhea and at least 50 years of age) are eligible.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
1. Prior systemic therapy for MCC, including chemotherapy and prior PD-
1– or PD-L1–directed therapy.
2. Treatment with anticancer drugs or participation in another interventional clinical study within 21 days before the first administration of study drug.
3. Participant has not recovered to = Grade 1 or baseline from toxic effects of prior therapy (with the exceptions for anemia not requiring transfusion support and any grade of alopecia) and/or complications from prior surgical intervention within 7 days before starting study treatment.
4. Radiation therapy administered within 2 weeks of first dose of study treatment or radiation therapy to the thoracic region that is > 30 Gy within 6 months of the first dose of study treatment.
5. Known CNS metastases and/or carcinomatous meningitis
6. Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for > 1 year, after treatment with curative intent.
7. Participants with laboratory values at screening as defined in protocol.
8. Evidence of interstitial lung disease or active, noninfectious
pneumonitis.
9. Participants with impaired cardiac function or clinically significant
cardiac disease:
a. New York Heart Association Class III or IV cardiac disease, including
preexisting clinically significant ventricular arrhythmia, congestive heart failure, or cardiomyopathy.
b. Unstable angina pectoris = 6 months before study participation.
c. Acute myocardial infarction = 6 months before study participation.
d. Other clinically significant heart disease (ie, uncontrolled = Grade 3
hypertension, history of labile hypertension, or poor compliance with an antihypertensive regimen). Must have recovered (to baseline or = Grade 1) from toxicity associated with prior treatment.
10. Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids.
11. Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
12. Known active hepatitis A, B, or C or active infections requiring
systemic antibiotics.
13. Has received a live vaccine within 9028 days of planned start of
study therapy.
Note: Examples of live vaccines include, but are not limited to, the
following: measles, mumps, rubella, chicken pox/zoster, yellow fever,
rabies, Bacillus Calmette–Guérin, and typhoid vaccine. Seasonal
influenza vaccines for injection are generally killed virus vaccines and
are allowed; however, intranasal influenza vaccines (eg, FluMist®) are
live-attenuated vaccines and are not allowed.
14. Current use of prohibited medication as described in Section 6.6.2.
15. Known hypersensitivity to another monoclonal antibody, which
cannot be controlled with standard measures (eg, antihistamines and
corticosteroids).
16. Participant lacks the ability or is unlikely, in the opinion of the
investigator, to comply with the Protocol requirements.
17. Participant who is pregnant or breastfeeding
18. Any condition that would, in the investigator's judgment, i

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified