NCT03304639|Active Not RecruitingPhase 2ResultsFDA Drug

Testing the Addition of Radiation Therapy to Immunotherapy for Merkel Cell Carcinoma

A Randomized Phase II Study of Anti-PD1 Antibody [MK-3475 (Pembrolizumab)] Alone Versus Anti-PD1 Antibody Plus Stereotactic Body Radiation Therapy in Advanced Merkel Cell Carcinoma

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2017-01817A091605U10CA180821

Study Type

interventional

Target

Locations

1 country

Sites

255

Timeline

RegisteredOct 2017

StartedJun 2018

CompletionSep 2026

Brief Summary

This randomized phase II trial studies how well pembrolizumab with or without stereotactic body radiation therapy works in treating patients with Merkel cell cancer that has spread to other places in the body (advanced). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving pembrolizumab with stereotactic body radiation therapy may work better in treating patients with Merkel cell cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

5mo left

Started Jun 2018

Longer than P75 for phase_2

Geographic Reach

1 country

255 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8.3 years study duration

Study Progress96%

Jun 2018Sep 2026

First Submitted

Initial submission to the registry

October 5, 2017

Completed

4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2017

Completed

8 months until next milestone

Study Start

First participant enrolled

June 12, 2018

Completed

4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2022

Completed

1.7 years until next milestone

Results Posted

Study results publicly available

February 8, 2024

Completed

2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2026

Expected

Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

October 5, 2017

Results QC Date

June 28, 2023

Last Update Submit

April 9, 2026

Conditions

Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8 Pathologic Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8 Pathologic Stage IIIA Cutaneous Merkel Cell Carcinoma AJCC v8 Pathologic Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 Advanced Merkel Cell Carcinoma Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8 Metastatic Merkel Cell Carcinoma Pathologic Stage IIIB Cutaneous Merkel Cell Carcinoma AJCC v8

Outcome Measures

Primary Outcomes (1)

Progression-free Survival (PFS)
Will compare PFS in non-radiated lesion(s) of patients receiving either (a) stereotactic body radiation therapy (SBRT) + pembrolizumab compared to (b) pembrolizumab alone in patients with advanced Merkel cell carcinoma. Kaplan- Meier curves will be constructed and median PFS times will be calculated for each arm. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
From randomization to either disease progression or death (without progression), assessed up to 3 years

Secondary Outcomes (6)

PFS Among All Response Evaluation Criteria in Solid Tumors Lesions
From randomization to either evidence of disease progression or death (without evidence of progression), assessed up to 3 years
Overall Response Rate
Up to 3 years
Progression-free Survival
At 6 months
Incidence of Adverse Events
Up to 3 months
PFS for Lesions Chosen for Radiation Prior to Randomization
Up to 3 years
+1 more secondary outcomes

Study Arms (2)

Group I (pembrolizumab)

ACTIVE COMPARATOR

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Biological: Pembrolizumab

Group II (pembrolizumab, SBRT)

EXPERIMENTAL

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.

Biological: PembrolizumabRadiation: Stereotactic Body Radiation Therapy

Interventions

PembrolizumabBIOLOGICAL

Given IV

Also known as: BCD-201, GME 751, GME751, Keytruda, Lambrolizumab, MK 3475, MK-3475, MK3475, Pembrolizumab Biosimilar BCD-201, Pembrolizumab Biosimilar GME751, Pembrolizumab Biosimilar QL2107, Pembrolizumab Biosimilar RPH-075, Pembrolizumab Biosimilar SB27, QL2107, RPH 075, RPH-075, RPH075, SB 27, SB-27, SB27, SCH 900475, SCH-900475, SCH900475

Group I (pembrolizumab)Group II (pembrolizumab, SBRT)

Stereotactic Body Radiation TherapyRADIATION

Undergo SBRT

Also known as: SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

Group II (pembrolizumab, SBRT)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients must have pathologically (histologically or cytologically) proven diagnosis of MCC by local pathology review
Have measurable disease based on RECIST 1.1 including at least two cancerous deposits; at least one deposit must be RECIST measurable while at least one deposit must meet criteria for SBRT; non-radiated tumor will be identified prior to randomization on the protocol
Patients must have advanced or metastatic MCC defined as evidence of distant metastasis(es) on imaging
Patients with locoregionally confined disease are not eligible
No prior immunotherapy for advanced/metastatic MCC
Patients with known or suspected central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded; however, subjects with controlled brain metastases will be allowed to enroll; controlled brain metastases are defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment (or 4 weeks of observation if no intervention is clinically indicated), and off of steroids for at least 2 weeks, and no new or progressive neurological signs and symptoms
Patients having received palliative radiotherapy for extracranial metastasis(es) are eligible as long as there are 2 cancerous deposits that have not received prior radiation therapy (RT) and they meet the following criteria
No prior radiation therapy (\> 5 Gy) to the metastasis intended to be treated with SBRT
No history of the following:
Autoimmunity requiring systemic immunosuppression within 2 years
Patients known to be human immunodeficiency virus (HIV) positive are eligible if they meet the following:
CD4 counts \>= 350 mm\^3
Serum HIV viral load of \< 25,000 IU/ml
No other active malignancy that the investigator determines would interfere with the treatment and safety analysis
Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown; therefore, for women of childbearing potential only, a negative (if your test schedule specifically indicates a urine or serum pregnancy test, add that information at this point) pregnancy test done =\< 28 days prior to registration is required
+12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead

Study Sites (255)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Alaska Breast Care and Surgery LLC