Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Carcinoma, Renal Cell

Carcinoma

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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.

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.

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

Pembrolizumab Pre-Resection

Standard of care surgical resection of RCC tumor

Surgical Resection

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

Pembrolizumab Post-Resection

Medical Director

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.

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

A Clinical Trial to Evaluate the Effect of Neoadjuvant MK-3475 (Pembrolizumab) Therapy on Intratumoral Immune Infiltrates in Renal Cell Cancer (RCC) Patients Undergoing Surgical Resection

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE during their regimen of neoadjuvant pembrolizumab was presented.

An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study drug due to an adverse event is presented.

The number of participants who received neoadjuvant pembrolizumab and showed a 2-fold or greater change from baseline in intratumoral CD3+ lymphocytic infiltration is presented. Evaluations were based on pathologist score.

The number of participants who received neoadjuvant pembrolizumab and showed a 2-fold or greater change from baseline in intratumoral CD8+ lymphocytic infiltration is presented. Evaluations were based on pathologist score.

The number of participants who received neoadjuvant pembrolizumab and showed a 2-fold or greater change from baseline in intratumoral FoxP3+ (forkhead box protein P3 positive) lymphocytic infiltration is presented. Evaluations were based on pathologist score.

The change from baseline in levels of gene expression of immune modulatory receptors in tumors of participants treated with neoadjuvant pembrolizumab was presented.

The change from baseline in number of T cells in tumors of participants treated with neoadjuvant pembrolizumab was presented.

The change from baseline in the number of activated T cells in peripheral blood of participants treated with neoadjuvant pembrolizumab was presented.

The change from baseline in levels of programmed cell death 1 ligand 1 (PD-L1) protein in tumors of participants treated with neoadjuvant pembrolizumab in participants who received neoadjuvant pembrolizumab was presented.

The change from baseline in levels of programmed cell death 1 ligand 2 (PD-L2) protein in tumors of participants treated with neoadjuvant pembrolizumab in participants who received neoadjuvant pembrolizumab was presented.

Merck Sharp & Dohme LLC

Adverse events are reported only for participants who received treatment as described in each arm's description. Deaths are reported for all participants who enrolled, regardless of whether they received treatment.

Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless it resulted in hospitalization or death.

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. Adverse events in this arm are only counted until 30 days after RCC resection for non-serious adverse events, 90 days for serious adverse events, or until a participant started the post-surgery course of pembrolizumab, whichever occurred first. Deaths are counted from the time of enrollment until a participant started the post-surgery course of pembrolizumab.

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. Adverse events and deaths in this arm are only counted after a participant started the post-surgery course of pembrolizumab.

Neoadjuvant Pembrolizumab+Resection+Post-Surgery Pembrolizumab

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. Adverse events in this arm are only counted until 30 days after RCC resection for non-serious adverse events, 90 days for serious adverse events, or until a participant started the post-surgery course of pembrolizumab, whichever occurred first. Deaths are counted from the time of enrollment until a participant started the post-surgery course of pembrolizumab.

SOC RCC Resection

Participants received SOC renal cell carcinoma (RCC) surgical resection; and then may have received post-resection pembrolizumab 200 mg IV 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. Adverse events and deaths in this arm are only counted after a participant started the post-surgery course of pembrolizumab.

RCC Resection + Post-Resection Pembrolizumab

RCC Resection

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Senior Vice President, Global Clinical Development

Per protocol, the analysis population consisted of all participants who received ≥1 dose of neoadjuvant pembrolizumab.

Number of Participants With an Adverse Event (AE) During the Neoadjuvant Pembrolizumab Regimen

During neoadjuvant pembrolizumab

During post-RCC resection pembrolizumab

The analysis population consisted of all participants who received ≥1 dose of pembrolizumab. Participants in the RCC Resection arm only received pembrolizumab if they enrolled under protocol amendment 04. Counts were based on which course of pembrolizumab (neoadjuvant or post-resection) a participant was receiving at the time of discontinuation.

Number of Participants Who Discontinued Treatment Due to an Adverse Event

The analysis population consisted of all participants who received ≥1 dose of neoadjuvant pembrolizumab and whose samples were evaluable.

Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral CD3+ Lymphocytic Infiltration

The analysis population was planned to consist of all participants who received ≥1 dose of neoadjuvant pembrolizumab. Due to low enrollment, there is no data to analyze for this outcome measure and therefore all participants were excluded from analysis.

Change From Baseline in Levels of Gene Expression of Immune Modulatory Receptors in Tumors of Participants Treated With Neoadjuvant Pembrolizumab

Change From Baseline in Number of T Cells in Tumors of Participants Treated With Neoadjuvant Pembrolizumab

Change From Baseline in Number of Activated T Cells in Peripheral Blood of Participants Treated With Neoadjuvant Pembrolizumab

Change From Baseline in Levels of Programmed Cell Death 1 Ligand 1 (PD-L1) Protein in Tumors of Participants Treated With Neoadjuvant Pembrolizumab

Change From Baseline in Levels of Programmed Cell Death 1 Ligand 2 (PD-L2) Protein in Tumors of Participants Treated With Neoadjuvant Pembrolizumab

Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral CD8+ Lymphocytic Infiltration

Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral FoxP3+ Lymphocytic Infiltration

Spots Global Cancer Trial Database for A Study Evaluating the Effect of Pembrolizumab (MK-3475) in Participants With Renal Cell Cancer (MK-3475-031)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial