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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002526-12 | EudraCT Number | ||
| MK-3475-031 | Other Identifier | Merck | |
| KEYNOTE-031 | Other Identifier | Merck |
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Terminated early due to low enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant Pembrolizumab + RCC Resection | Experimental | 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. |
|
| RCC Resection | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab Pre-Resection | Drug | 200 mg administered by IV, once every 3-week cycle for a maximum of 2 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Adverse Event (AE) During the Neoadjuvant Pembrolizumab Regimen | 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. | Up to Week 16 |
| Number of Participants Who Discontinued Treatment Due to an Adverse Event | 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. | Up to 56 weeks |
| Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral CD3+ Lymphocytic Infiltration | 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. | Baseline and Week 7 |
| Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral CD8+ Lymphocytic Infiltration | 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. | Baseline and Week 7 |
| Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral FoxP3+ Lymphocytic Infiltration | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Levels of Gene Expression of Immune Modulatory Receptors in Tumors of Participants Treated With Neoadjuvant Pembrolizumab | The change from baseline in levels of gene expression of immune modulatory receptors in tumors of participants treated with neoadjuvant pembrolizumab was presented. | Baseline and Week 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With an Adverse Event (AE) During the Neoadjuvant Pembrolizumab Regimen | 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. | Per protocol, the analysis population consisted of all participants who received ≥1 dose of neoadjuvant pembrolizumab. | Posted | Count of Participants | Participants | Up to Week 16 |
|
Up to 77 weeks
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infections and infestations | Infections and infestations | MedDRA 22.0 | Systematic Assessment | Due to the small sample size for this study, we are not disclosing the specific Adverse Event term for this Adverse Event due to patient confidentiality concerns. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye disorders | Eye disorders | MedDRA 22.0 | Systematic Assessment | Due to the small sample size for this study, we are not disclosing the specific Adverse Event term for this Adverse Event due to patient confidentiality concerns. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2018 | Jun 22, 2020 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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| Surgical Resection | Procedure | Standard of care surgical resection of RCC tumor |
|
| Pembrolizumab Post-Resection | Drug | 200 mg administered by IV, once every 3-week cycle for a maximum of 17 cycles |
|
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| Baseline and Week 7 |
| Change From Baseline in Number of T Cells in Tumors of Participants Treated With Neoadjuvant Pembrolizumab |
The change from baseline in number of T cells in tumors of participants treated with neoadjuvant pembrolizumab was presented. |
| Baseline and Week 7 |
| Change From Baseline in Number of Activated T Cells in Peripheral Blood of Participants Treated With Neoadjuvant Pembrolizumab | The change from baseline in the number of activated T cells in peripheral blood of participants treated with neoadjuvant pembrolizumab was presented. | Baseline and Week 7 |
| Change From Baseline in Levels of Programmed Cell Death 1 Ligand 1 (PD-L1) Protein in Tumors of Participants Treated With Neoadjuvant Pembrolizumab | 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. | Baseline and Week 7 |
| Change From Baseline in Levels of Programmed Cell Death 1 Ligand 2 (PD-L2) Protein in Tumors of Participants Treated With Neoadjuvant Pembrolizumab | 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. | Baseline and Week 7 |
| Disease progression prior to RCC surgery |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
|
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| Primary | Number of Participants Who Discontinued Treatment Due to an Adverse Event | 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 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. | Posted | Count of Participants | Participants | Up to 56 weeks |
|
|
|
| Primary | Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral CD3+ Lymphocytic Infiltration | 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 analysis population consisted of all participants who received ≥1 dose of neoadjuvant pembrolizumab and whose samples were evaluable. | Posted | Count of Participants | Participants | Baseline and Week 7 |
|
|
|
| Secondary | Change From Baseline in Levels of Gene Expression of Immune Modulatory Receptors in Tumors of Participants Treated With Neoadjuvant Pembrolizumab | The change from baseline in levels of gene expression of immune modulatory receptors in tumors of participants treated with neoadjuvant pembrolizumab was presented. | 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. | Posted | Baseline and Week 7 |
|
|
| Secondary | Change From Baseline in Number of T Cells in Tumors of Participants Treated With Neoadjuvant Pembrolizumab | The change from baseline in number of T cells in tumors of participants treated with neoadjuvant pembrolizumab was presented. | 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. | Posted | Baseline and Week 7 |
|
|
| Secondary | Change From Baseline in Number of Activated T Cells in Peripheral Blood of Participants Treated With Neoadjuvant Pembrolizumab | The change from baseline in the number of activated T cells in peripheral blood of participants treated with neoadjuvant pembrolizumab was presented. | 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. | Posted | Baseline and Week 7 |
|
|
| Secondary | Change From Baseline in Levels of Programmed Cell Death 1 Ligand 1 (PD-L1) Protein in Tumors of Participants Treated With Neoadjuvant Pembrolizumab | 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 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. | Posted | Baseline and Week 7 |
|
|
| Secondary | Change From Baseline in Levels of Programmed Cell Death 1 Ligand 2 (PD-L2) Protein in Tumors of Participants Treated With Neoadjuvant Pembrolizumab | 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. | 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. | Posted | Baseline and Week 7 |
|
|
| Primary | Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral CD8+ Lymphocytic Infiltration | 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 analysis population consisted of all participants who received ≥1 dose of neoadjuvant pembrolizumab and whose samples were evaluable. | Posted | Count of Participants | Participants | Baseline and Week 7 |
|
|
|
| Primary | Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral FoxP3+ Lymphocytic Infiltration | 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 analysis population consisted of all participants who received ≥1 dose of neoadjuvant pembrolizumab and whose samples were evaluable. | Posted | Count of Participants | Participants | Baseline and Week 7 |
|
|
|
| 0 |
| 6 |
| 1 |
| 4 |
| 4 |
| 4 |
| EG001 | Neoadjuvant Pembrolizumab+Resection+Post-Surgery Pembrolizumab | 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. | 0 | 1 | 1 | 1 | 1 | 1 |
| EG002 | SOC 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. 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. | 1 | 4 | 0 | 3 | 0 | 3 |
| EG003 | RCC Resection + Post-Resection Pembrolizumab | 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. | 0 | 1 | 0 | 1 | 1 | 1 |
|
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment | Due to the small sample size for this study, we are not disclosing the specific Adverse Event term for this Adverse Event due to patient confidentiality concerns. |
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| General disorders and administration site conditions | General disorders | MedDRA 22.0 | Systematic Assessment | Due to the small sample size for this study, we are not disclosing the specific Adverse Event term for this Adverse Event due to patient confidentiality concerns. |
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| General disorders and administration site conditions | General disorders | MedDRA 22.0 | Systematic Assessment | Due to the small sample size for this study, we are not disclosing the specific Adverse Event term for this Adverse Event due to patient confidentiality concerns. |
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| General disorders and administration site conditions | General disorders | MedDRA 22.0 | Systematic Assessment | Due to the small sample size for this study, we are not disclosing the specific Adverse Event term for this Adverse Event due to patient confidentiality concerns. |
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| General disorders and administration site conditions | General disorders | MedDRA 22.0 | Systematic Assessment | Due to the small sample size for this study, we are not disclosing the specific Adverse Event term for this Adverse Event due to patient confidentiality concerns. |
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| Investigations | Investigations | MedDRA 22.0 | Systematic Assessment | Due to the small sample size for this study, we are not disclosing the specific Adverse Event term for this Adverse Event due to patient confidentiality concerns. |
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| Investigations | Investigations | MedDRA 22.0 | Systematic Assessment | Due to the small sample size for this study, we are not disclosing the specific Adverse Event term for this Adverse Event due to patient confidentiality concerns. |
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| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment | Due to the small sample size for this study, we are not disclosing the specific Adverse Event term for this Adverse Event due to patient confidentiality concerns. |
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| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment | Due to the small sample size for this study, we are not disclosing the specific Adverse Event term for this Adverse Event due to patient confidentiality concerns. |
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| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment | Due to the small sample size for this study, we are not disclosing the specific Adverse Event term for this Adverse Event due to patient confidentiality concerns. |
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| Nervous system disorders | Nervous system disorders | MedDRA 22.0 | Systematic Assessment | Due to the small sample size for this study, we are not disclosing the specific Adverse Event term for this Adverse Event due to patient confidentiality concerns. |
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| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment | Due to the small sample size for this study, we are not disclosing the specific Adverse Event term for this Adverse Event due to patient confidentiality concerns. |
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| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment | Due to the small sample size for this study, we are not disclosing the specific Adverse Event term for this Adverse Event due to patient confidentiality concerns. |
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The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| During post-RCC resection pembrolizumab |
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