A Study Evaluating the Effect of Pembrolizumab (MK-3475) in Participants With Renal Cell Cancer (MK-3475-031)

NCT ID: NCT02212730

Last Updated: 2020-07-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-03
• Study Completion Date: 2019-07-05

Brief Summary

This study will examine the effect of treatment with the neoadjuvant antibody pembrolizumab (MK-3475) on tumors of participants with renal cell cancer (RCC). The primary hypotheses are that pembrolizumab is well tolerated in participants undergoing RCC tumor resection; and that pembrolizumab will stimulate a 2-fold or greater increase in intratumoral lymphocytic infiltration in at least 30% of participants with RCC.

Conditions

Renal Cell Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant Pembrolizumab + RCC Resection

Participants received pembrolizumab, 200 mg intravenously (IV) once every 3-week cycle for up to 2 cycles followed by standard of care (SOC) renal cell carcinoma (RCC) surgical resection; and then received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled after Protocol Amendment 04.

Group Type: EXPERIMENTAL

Pembrolizumab Pre-Resection

Intervention Type: DRUG

200 mg administered by IV, once every 3-week cycle for a maximum of 2 cycles

Surgical Resection

Intervention Type: PROCEDURE

Standard of care surgical resection of RCC tumor

Pembrolizumab Post-Resection

Intervention Type: DRUG

200 mg administered by IV, once every 3-week cycle for a maximum of 17 cycles

RCC Resection

Participants received SOC renal cell carcinoma (RCC) surgical resection; and then may have received post-resection pembrolizumab 200 mg IV once every 3 week cycle for up to approximately 1 year (17 cycles). Post-resection pembrolizumab was only administered to participants who enrolled under Protocol Amendment 04.

Group Type: EXPERIMENTAL

Surgical Resection

Intervention Type: PROCEDURE

Standard of care surgical resection of RCC tumor

Pembrolizumab Post-Resection

Intervention Type: DRUG

200 mg administered by IV, once every 3-week cycle for a maximum of 17 cycles

Interventions

Pembrolizumab Pre-Resection

200 mg administered by IV, once every 3-week cycle for a maximum of 2 cycles

Intervention Type: DRUG

Surgical Resection

Standard of care surgical resection of RCC tumor

Intervention Type: PROCEDURE

Pembrolizumab Post-Resection

200 mg administered by IV, once every 3-week cycle for a maximum of 17 cycles

Intervention Type: DRUG

Other Intervention Names

KEYTRUDA®; MK-3475; KEYTRUDA®; MK-3475

Eligibility Criteria

Inclusion Criteria

• Have a newly diagnosed RCC, with a primary tumor diameter of more than 4 cm (>= T1b), not previously treated, and be a candidate for operative tumor resection
• Be willing and able to undergo pre-treatment baseline image-guided core biopsy of their primary RCC
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
• Demonstrate adequate organ function
• Female is not breast feeding, is postmenopausal or surgically sterile; demonstrates non-pregnant state, and agrees to use two acceptable methods of birth control throughout the trial, until 120 days after the last dose of treatment
• Male with female partner of childbearing potential agrees to use adequate method of contraception throughout study, until 120 days after last dose of treatment or last blood draw.

Exclusion Criteria

• Is currently participating in, or has participated in a study with an investigational agent or device within 4 weeks prior to first dose of study therapy
• Has a diagnosis of immunosuppression or has received systemic steroid therapy, or any other form of immunosuppressive therapy within 4 weeks prior to first dose of study therapy
• Has had prior chemotherapy, targeted small molecule, or radiation therapy for treatment of RCC
• Has a known additional (other than RCC) malignancy that is progressing or requires active treatment
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has an active, or documented history of autoimmune disease, with the exceptions of vitiligo or resolved childhood asthma/atopy
• Has a history of (non-infectious) pneumonitis that required treatment with steroids or current pneumonitis.
• Has an active infection requiring systematic therapy
• Is receiving anticoagulant therapy, with the exception of low dosage aspirin
• Has severe cardiovascular disease or symptomatic ischemic heart disease
• Has hepatic decompensation
• Has uncontrolled thyroid dysfunction
• Has uncontrolled diabetes mellitus
• Has known psychiatric or substance abuse disorders
• Female is pregnant or breastfeeding
• Is expecting to conceive children within the projected maximum duration of the trial, extending through 120 days after the last dose of treatment or the last blood draw
• Has received prior therapy with any antibody or drug (including ipilimumab) specifically targeting T-cell co-stimulation or checkpoint pathway
• Has a known history of human immunodeficiency virus (HIV)
• Has known active hepatitis B or C
• Has received a live vaccine within 30 days prior to screening

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2014-002526-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-3475-031

Identifier Type: OTHER

Identifier Source: secondary_id

KEYNOTE-031

Identifier Type: OTHER

Identifier Source: secondary_id

3475-031

Identifier Type: -

Identifier Source: org_study_id