Loading clinical trials...

MK-3475 as Maintenance Therapy in Extensive Stage SCLC | Clinical Trials | Clareo Health

COMPLETEDPHASE2

MK-3475 as Maintenance Therapy in Extensive Stage SCLC

Phase II Study of MK-3475 as Maintenance Therapy in Extensive Stage Small Cell Lung Cancer (SCLC) Patients

NCT02359019•Barbara Ann Karmanos Cancer Institute

Summary

This phase II trial studies how well pembrolizumab works in treating patients with extensive stage small cell lung cancer after completion of combination chemotherapy. Pembrolizumab may be effective in controlling small cell lung cancer for a longer period of time in patients with responsive or stable disease after completion of combination chemotherapy.

Detailed Description

PRIMARY OBJECTIVES: I. To assess Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 defined progression-free survival (PFS) in extensive stage small cell lung cancer (SCLC) patients, who have complete response (CR), partial response (PR) or stable disease following minimum of 4 cycles of platinum (cisplatin or carboplatin) and etoposide. SECONDARY OBJECTIVES: I. To assess modified PFS in all patients enrolled. II. To assess overall survival of patients enrolled on the trial. III. To assess programmed cell death 1 ligand 1 (PD-L1) expression in archival tumor tissues and in circulating tumor cells (CTCs) and correlate the expression to RECIST defined PFS. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days and then every 12 weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with extensive stage SCLC who have completed at least 4 cycles of platinum (carboplatin/cisplatin) and etoposide chemotherapy as their first line therapy and have responding or stable disease to this therapy are eligible for this study; patients who received platinum/etoposide previously for SCLC and it was repeated for recurrence will not be eligible
•Patients should be willing and able to provide written informed consent for the trial
•Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
•Demonstrate adequate organ function, all screening laboratories (labs) should be performed within 14 days of treatment initiation
•Absolute neutrophil count (ANC) \>= 1,500/mcL
•Platelets \>= 100,000/mcL
•Hemoglobin \>= 9 g/dL or \>= 5.6 mmol/L
•Serum creatinine =\< 1.5 X upper limit of normal (ULN) OR measured or calculated\* creatinine clearance \>= 45 mL/min for subject with creatinine levels \> 1.5 X institutional ULN; glomerular filtration rate (GFR) can also be used in place of creatinine or creatinine clearance \[CrCl\])
•* Creatinine clearance should be calculated per institutional standard
•Serum total bilirubin =\< 1.5 X ULN OR directed bilirubin =\< ULN for subjects with total bilirubin levels \> 1.5 ULN
+15 more criteria

Exclusion Criteria

•Is currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment
•Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy greater than 10 mg/day or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
•Has had a prior monoclonal antibody within 4 weeks prior to study day 1 or who has not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
•Has had prior chemotherapy, targeted small molecule therapy, or definitive radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =\< grade 1 or at baseline) from adverse events due to a previously administered agent; patients who received palliative radiation to any site or prophylactic cranial radiation (=\< 30 Gray \[Gy\]) or thoracic RT can start therapy with the study drug 7 days after the last day of radiation therapy as long as they have recovered from any adverse effects (i.e., =\< grade 1 or at baseline) of such radiation therapy
•* Note: subjects with =\< grade 2 neuropathy or adverse events that are not considered clinically meaningful such as alopecia are an exception to this criterion and may qualify for the study
•* Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy

Locations (5)

Rush University Medical Center

Chicago, Illinois, United States

University of Michigan

Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Cleveland Clinic

Cleveland, Ohio, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Key Dates

Start Date

February 1, 2015

Primary Completion Date

October 1, 2018

Completion Date

October 1, 2018

Last Updated

October 14, 2022

Enrollment

ACTUAL participants

Conditions

Extensive Stage Small Cell Lung Carcinoma

Interventions

Pembrolizumab

BIOLOGICAL

Laboratory Biomarker Analysis

OTHER

Talazoparib and Low-Dose Temozolomide in Treating Participants With Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer

NCT03672773

Recurrent Extensive Stage Small Cell Lung CarcinomaRefractory Extensive Stage Small Cell Lung Carcinoma

View study

COMPLETEDPHASE1/PHASE2

Sirolimus and Auranofin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer or Small Cell Lung Cancer

NCT01737502

Extensive Stage Small Cell Lung CarcinomaLung Adenocarcinoma+6 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 14, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

MK-3475 as Maintenance Therapy in Extensive Stage SCLC

Inclusion Criteria

Exclusion Criteria

Talazoparib and Low-Dose Temozolomide in Treating Participants With Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer

Sirolimus and Auranofin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer or Small Cell Lung Cancer

Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer

Tumor-Treating Fields Therapy in Preventing Brain Tumors in Participants With Extensive-Stage Small Cell Lung Cancer

A Study of LY2510924 in Participants With Extensive-Stage Small Cell Lung Carcinoma