Study of Preladenant (MK-3814) Alone and With Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3814A-062)

Browse trials for

• Neoplasms 9,610
• Parkinson Disease 4, Autosomal Dominant Lewy Body 156

Keywords

• Advanced Solid Tumor
• Programmed Cell Death Receptor 1 (PD-1)
• Programmed Cell Death Receptor Ligand 1 (PD-L1)
• PD1
• PD-1
• PDL1
• PD-L1

Neoplasms

9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 10 is below the median of 50 across 7,429 interventional studies indexed under Neoplasms.

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.

Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.

Study arms

• Experimental
  Preladenant 25 mg Twice a Day (BID)

  During an initial dose evaluation phase, participants received 25 mg of preladenant orally twice a day (BID) on Days 1 through 21 of each 21-day cycle (for a maximum of 35 cycles) until the RP2D could be established. The RP2D was to be established based on the number of dose limiting toxicities (DLTs) at each dose level administered. Participants continued receiving 25 mg of preladenant BID on Days 1 through 21 of each infusion cycle until discontinuation or receiving a maximum of 35 cycles.

  Drug: preladenant

• Experimental
  Preladenant 50 mg BID

  During an initial dose evaluation phase, participants received 50 mg of preladenant orally BID on Days 1 through 21 of each 21-day cycle (for a maximum of 35 cycles) until the RP2D could be established. The RP2D was established based on the number of DLTs at each dose level administered. Participants continued receiving 50 mg of preladenant BID on Days 1 through 21 of each infusion cycle until discontinuation or receiving a maximum of 35 cycles.

  Drug: preladenant

• Experimental
  Preladenant + Pembrolizumab

  During an initial dose evaluation phase, participants received 25 mg of preladenant administered orally BID on Days 1 through 21 in combination with 200 mg pembrolizumab administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (for a maximum of 35 cycles). Participants continued receiving preladenant 25 mg BID in combination with 200 mg pembrolizumab for each infusion cycle until discontinuation or receiving a maximum of 35 cycles.

  Drug: preladenant · Biological: pembrolizumab

Interventions

• Drugpreladenant

  Administered as an oral capsule BID on Days 1 through 21 of each 21-day cycle

  Also known as: MK-3814A

• Biologicalpembrolizumab

  Administered as IV infusion on Day 1 of each 21-day cycle

  Also known as: KEYTRUDA®, MK-3475

Primary outcomes

1. Number of Participants With Dose-limiting Toxicities (DLTs)

   DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4. A DLT was defined as any of the following events: Grade (Gr) 4 non-hematologic toxicity (not laboratory); Gr 4 hematologic toxicity lasting ≥7 days; Gr 4 thrombocytopenia of any duration; Gr 3 thrombocytopenia with bleeding; Gr 3 non-hematologic toxicity (not laboratory) lasting \>3 days despite optimal supportive care; Gr 3 or Gr 4 non-hematologic laboratory value requiring treatment, hospitalization, or persisting for \>72 hours; alanine aminotransferase (ALT) or aspartate aminotransferase(AST) \>3X upper limit of normal (ULN) WITH total bilirubin \>2X ULN with no elevation in alkaline phosphatase (\<2X ULN); Febrile neutropenia Gr 3 or 4; discontinuation during Cycle 1 or a \>2 week delay in initiating Cycle 2 due to treatment-related toxicity; Missing \>25% of preladenant doses as a result of adverse events during Cycle 1; or Gr 5 toxicity.

   Time frame: Cycle 1 (up to 21 days)

2. Number of Participants Who Experienced at Least One Adverse Event (AE)

   An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. The number of participants who experienced at least one AE is presented.

   Time frame: Up tp approximately 8 months

3. Number of Participants Who Discontinued Study Treatment Due to an AE

   An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. The number of participants who discontinued study treatment due to an AE is presented.

   Time frame: Up to approximately 8 months

Secondary outcomes

1. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

   ORR was defined as the percentage of the participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 per investigator review. The ORR per RECIST 1.1 for participants is presented.

   Time frame: Up to approximately 8 months

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Mar 30, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Data sharing details ↗ · engagezone.msd.com