KEYMAKER-U01 Master Study: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents, Pembrolizumab, and Chemotherapy, Alone or in Combination, in Participants With Non-small Cell Lung Cancer (NSCLC)
Merck Sharp & Dohme LLC
Summary
This study is referred to as the "umbrella master protocol" for pembrolizumab (MK-3475) in the treatment of non-small cell lung cancer (NSCLC). This pembrolizumab NSCLC umbrella master protocol uses a platform design and consists of this master screening study and additional substudies. Each substudy will enroll a different population of NSCLC participants.
Description
The following pembrolizumab substudies will evaluate the efficacy of different investigational agents in combination with pembrolizumab given in sequence or in combination with pembrolizumab PLUS chemotherapy: * KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents, With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A) - NCT04165070 * KEYMAKER-U01 Substudy 2: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents in Combination with Pembrolizumab…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC * Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has an active autoimmune disease that has required systemic treatment in the past 2 years * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/inter…
Interventions
- Diagnostic TestTumor Imaging
Participants will undergo tumor imaging using either a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan.
- ProcedureTumor Tissue Collection
Participants without archival tumor tissue samples will undergo tumor tissue collection for newly obtained tumor tissue.
- ProcedureBlood Sample Collection
Participants will have blood samples drawn for analysis of: * genetics * ribonucleic acid (RNA) * serum biomarker * plasma biomarker * circulating tumor DNA (ctDNA)
Locations (47)
- Banner MD Anderson Cancer Center ( Site 0001)Gilbert, Arizona
- City of Hope ( Site 0014)Duarte, California
- UCSF Medical Center at Mission Bay ( Site 0007)San Francisco, California
- Georgetown University ( Site 0036)Washington D.C., District of Columbia
- University of Kentucky Markey Cancer Center ( Site 0019)Lexington, Kentucky
- MedStar Franklin Square Medical Center ( Site 0033)Baltimore, Maryland