Trial Outcomes & Findings for Palliative RT & Anti-PD-1/PD-L1 Checkpoint Blockade in Metastatic Merkel Cell Carcinoma (NCT NCT03988647)

Last Updated: 2021-08-09

Results Overview

Tumor Response at both irradiated \& unirradiated sites will be measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Basic RECIST response will be assessed by the criterion below. * Complete Response (CR) = Disappearance of all target lesions. * Partial Response (PR) = ≥0% decrease in the sum of the longest diameter (LD) of target lesions. * Stable disease (SD) = Small changes that do not meet any of the above criteria. RECIST v1.1 immune-related response will be assessed by the criterion below. * Immune-related CR (irCR) = Disappearance of all target lesions. Lymph nodes \<10 mm in short axis. * Immune-related PR (irPR) = ≥30% decrease in the sum of the LD of target lesions. * Immune-related SD (irSD) = Failure to meet criteria for irCR or irPR in the absence of irPR. The outcome is reported as the number of lesions with each of the different levels of clinical response, a number without dispersion.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

15 months

Results posted on

2021-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Pembrolizumab + Palliative Radiation Therapy Pembrolizumab will be administered at 200 mg IV every 3 weeks as standard of care. Palliative radiation therapy will be given between the first and second cycles of immunotherapy Pembrolizumab: Pembrolizumab administered at 200 mg IV every 3 weeks Radiation Therapy: 9 Gy X 3 (27 Gy in 3 fractions), or 4-6 Gy X 5 (20-30 Gy in 5 fractions).
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Palliative RT & Anti-PD-1/PD-L1 Checkpoint Blockade in Metastatic Merkel Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab + Palliative Radiation Therapy n=1 Participants Pembrolizumab will be administered at 200 mg IV every 3 weeks as standard of care. Palliative radiation therapy will be given between the first and second cycles of immunotherapy Pembrolizumab: Pembrolizumab administered at 200 mg IV every 3 weeks Radiation Therapy: 9 Gy X 3 (27 Gy in 3 fractions), or 4-6 Gy X 5 (20-30 Gy in 5 fractions).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 15 months

Population: Note that basic clinical response and immune-related clinical response are distinct assessments, and each are reported for the participant.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Palliative Radiation Therapy n=1 Participants Pembrolizumab will be administered at 200 mg IV every 3 weeks as standard of care. Palliative radiation therapy will be given between the first and second cycles of immunotherapy Pembrolizumab: Pembrolizumab administered at 200 mg IV every 3 weeks Radiation Therapy: 9 Gy X 3 (27 Gy in 3 fractions), or 4-6 Gy X 5 (20-30 Gy in 5 fractions).
Tumor Response Complete Response (CR)	0 tumor lesions
Tumor Response Partial Response (PR)	0 tumor lesions
Tumor Response Stable disease (SD)	1 tumor lesions
Tumor Response Immune-related complete response (irCR)	0 tumor lesions
Tumor Response Immune-related partial response (irPR)	0 tumor lesions
Tumor Response Immune-related stable disease (irSD)	1 tumor lesions

SECONDARY outcome

Timeframe: 18 months

Overall survival (OS) was assessed as the duration of time from study entry to time of death or the date of last contact. The outcome is reported as OS in months.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Palliative Radiation Therapy n=1 Participants Pembrolizumab will be administered at 200 mg IV every 3 weeks as standard of care. Palliative radiation therapy will be given between the first and second cycles of immunotherapy Pembrolizumab: Pembrolizumab administered at 200 mg IV every 3 weeks Radiation Therapy: 9 Gy X 3 (27 Gy in 3 fractions), or 4-6 Gy X 5 (20-30 Gy in 5 fractions).
Overall Survival (OS)	18 months

SECONDARY outcome

Timeframe: 15 months

Population: Results are reported as the duration of response for each level of tumor response.

The duration of response (DoR) is measured from the time the criteria are met for CR or PR (whichever is first recorded) until the date that recurrent or progressive disease is documented. Tumor response at both irradiated \& unirradiated sites will be measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Basic RECIST response will be assessed by the criterion below. * CR = Disappearance of all target lesions. * PR = ≥0% decrease in the sum of the longest diameter (LD) of target lesions. * SD = Small changes that do not meet any of the above criteria. RECIST immune-related response will be assessed by the criterion below. * irCR = Disappearance of all target lesions. Lymph nodes \<10 mm in short axis. * irPR = ≥30% decrease in the sum of the LD of target lesions. * irSD = Failure to meet criteria for irCR or irPR in the absence of irPR. The outcome is reported as the duration of response for each level of level of clinical response.

Outcome measures

Outcome measures
Measure	Pembrolizumab + Palliative Radiation Therapy n=2 lesions Pembrolizumab will be administered at 200 mg IV every 3 weeks as standard of care. Palliative radiation therapy will be given between the first and second cycles of immunotherapy Pembrolizumab: Pembrolizumab administered at 200 mg IV every 3 weeks Radiation Therapy: 9 Gy X 3 (27 Gy in 3 fractions), or 4-6 Gy X 5 (20-30 Gy in 5 fractions).
Duration of Response (DOR) Stable disease (SD)	15 months
Duration of Response (DOR) Immune-related stable (irSD)	15 months

Adverse Events

Pembrolizumab + Palliative Radiation Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pembrolizumab + Palliative Radiation Therapy n=1 participants at risk Pembrolizumab will be administered at 200 mg IV every 3 weeks as standard of care. Palliative radiation therapy will be given between the first and second cycles of immunotherapy Pembrolizumab: Pembrolizumab administered at 200 mg IV every 3 weeks Radiation Therapy: 9 Gy X 3 (27 Gy in 3 fractions), or 4-6 Gy X 5 (20-30 Gy in 5 fractions).
Respiratory, thoracic and mediastinal disorders Cough	100.0% 1/1 • Number of events 1 • 532 days
Blood and lymphatic system disorders Anemia	100.0% 1/1 • Number of events 1 • 532 days
Investigations Lymphocyte decreased	100.0% 1/1 • Number of events 1 • 532 days
Investigations Alanine transferase increase	100.0% 1/1 • Number of events 1 • 532 days
Metabolism and nutrition disorders Hyperglycemia	100.0% 1/1 • Number of events 1 • 532 days
Skin and subcutaneous tissue disorders Alopecia	100.0% 1/1 • Number of events 1 • 532 days
General disorders Back Pain	100.0% 1/1 • Number of events 1 • 532 days
Respiratory, thoracic and mediastinal disorders Nasal congestion	100.0% 1/1 • Number of events 1 • 532 days
Cardiac disorders Chest pain	100.0% 1/1 • Number of events 1 • 532 days

Additional Information

Susan J Knox, Associate Professor of Radiation Oncology

Stanford University

Phone: 650-725-2720

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place