Neoplasms

All Conditions

Infections

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Merkel Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Adenocarcinoma

Neoplasms, Nerve Tissue

Merkel Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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 administered at 200 mg IV every 3 weeks

9 Gy X 3 (27 Gy in 3 fractions), or 4-6 Gy X 5 (20-30 Gy in 5 fractions).

Radiation Therapy

Susan J Knox, MD

The primary objectives of this study are to assess 1) the safety and 2) efficacy of combining Anti-PD-1/PD-L1 blockade with palliative radiation therapy in patients with Stage IV Merkel Cell Carcinoma.

The hypothesis for this study is that local radiation therapy (RT) can be safely used in combination with PD-1/PD-L1 blockade. This combination therapy may have the potential to enhance the induction of systemic anti-Merkel cell carcinoma immune responses, which will inhibit growth and kill Merkel cell tumor cells in sites of established metastases outside of the local radiation therapy field.

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

A Phase 2 Study of Palliative Radiation Therapy and Anti-PD-1/PD-L1 Checkpoint Blockade in Patients With Metastatic Merkel Cell Carcinoma

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.

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.

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.

Stanford University

Associate Professor of Radiation Oncology

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).

Pembrolizumab + Palliative Radiation Therapy

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Susan J Knox, Associate Professor of Radiation Oncology

Complete Response (CR)

Partial Response (PR)

Stable disease (SD)

Immune-related complete response (irCR)

Immune-related partial response (irPR)

Immune-related stable disease (irSD)

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

Tumor Response

Overall Survival (OS)

Immune-related complete response

Immune-related stable (irSD)

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

Duration of Response (DOR)

Overall Study

Spots Global Cancer Trial Database for Palliative RT & Anti-PD-1/PD-L1 Checkpoint Blockade in Metastatic Merkel Cell Carcinoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial