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Phase I Trial of MK-3475 and Concurrent Chemo/Radiation for the Elimination of Small Cell Lung Cancer

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Cancer

Intervention: Etoposide phosphate (Drug); Cisplatin (Drug); Carboplatin (Drug); MK-3475 (Drug); Radiation Therapy (Radiation)

Phase: Phase 1

Status: Recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
James Welsh, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Overall contact:
James Welsh, MD, Phone: 713-563-2300

Summary

The goal of this clinical research study is to find the highest tolerable dose of pembrolizumab (also called MK-3475) and radiation therapy (either with chemotherapy or alone) that can be given to patients with SCLC.

Clinical Details

Official title: Phase I Trial of MK-3475 and Concurrent Chemo/Radiation for the Elimination of Small Cell Lung Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximum Tolerated Dose (MTD) of MK 3475

Secondary outcome: Progression Free Survival (PFS)

Detailed description: Study Groups: If you are found to be eligible to take part in this study, you will be assigned to a part and study group based on when you join this study. Up to 3 groups of 3 participants each will be enrolled in Part A and up to 80 participants will be enrolled in Part B. If you are enrolled in Part A, the dose of pembrolizumab you receive will depend on when you join this study. The first group of participants will receive the lowest dose level of pembrolizumab. Each new group will receive a higher dose of pembrolizumab than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of pembrolizumab is found. In addition to pembrolizumab, participants in Part A will also receive either cisplatin and etoposide or carboplatin and etoposide. If you are enrolled in Part B, you will receive pembrolizumab at the highest dose that was tolerated in Part A. Participants in Part A will receive pembrolizumab during radiation therapy. The radiation will be to the chest area. Study Drug Administration: You will receive pembrolizumab by vein over about 30 minutes on Day 1 of each 3-week cycle. If you are in Group A, on Day 1 of Cycles 1-16, you will receive pembrolizumab by vein over 30 minutes. In addition, on Day 1 of Cycles 1-4, you will receive cisplatin by vein over about 2 hours and etoposide by vein over 4 hours on Days 1, 2, and 3. If you are unable to tolerate cisplatin, you will receive carboplatin by vein over 30 minutes and etoposide by vein over 4 hours on Days 1, 2, and 3. Study Visits: When you are not receiving radiation, you will have these every 3 weeks.

- You will have a physical exam.

- Blood (about 1 tablespoon) may be drawn for routine tests.

Follow Up: Every 12 weeks after your last dose of pembrolizumab, you will have CT or PET scans to check the status of the disease. You will also have PFTs performed. If you are unable to make these visits, you will be contacted by phone to check your health. Length of Study: You may continue taking the study drug for up to 16 doses. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. This is an investigational study. Radiation therapy is delivered using FDA-approved and commercially available methods for local control of metastatic and primary tumors. Pembrolizumab is FDA approved and commercially available for the treatment of unresectable or metastatic melanoma. It use in this study is investigational. Up to 80 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Be willing and able to provide written informed consent/assent for the trial 2. Be >/= 18 years of age on day of signing informed consent 3. Have a performance status of 0 or 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale 4. Demonstrate adequate organ function as defined here, all screening labs should be performed within 10 days of treatment initiation: Adequate Organ Function Laboratory Values- * Hematological; Absolute neutrophil count (ANC) >/=1,500 /mcL, Platelets >/=100,000 / mcL, Hemoglobin >/=9 g/dL or >/=5. 6 mmol/L * Renal; Serum creatinine or Measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) /=60 mL/min for subject with creatinine levels >1. 5 X institutional ULN [Creatinine clearance should be calculated per institutional standard] *Hepatic; Serum total bilirubin 1. 5 ULN, aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) and 5. Inclusion #5 continued: alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (SGPT) 1 year. 8. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. 9. Histologic diagnosis of either limited state SCLC (LS-SCLC), or Extensive stage SCLC (ES-SCLC) or neuroendocrine tumor. Exclusion Criteria: 1. Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 2 weeks of the first dose of treatment. 2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. With the exception of physiologic steroid replacement. 3. Has had a prior monoclonal antibody within 2 weeks prior to study Day 1 or who has not recovered (i. e.,

Locations and Contacts

James Welsh, MD, Phone: 713-563-2300

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: July 2015
Last updated: July 22, 2015

Page last updated: August 23, 2015

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