Renal Cell CancerPhase 1NCT02212730

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

A Phase 1 study testing Pembrolizumab Pre-Resection, Surgical Resection and Pembrolizumab Post-Resection in people with Renal Cell Cancer, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Renal Cell Cancer
What is being tested?: Pembrolizumab Pre-Resection, Surgical Resection and Pembrolizumab Post-Resection
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: No sites listed yet
Study dates: 3 Dec 2014to 5 Jul 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 20Show fewer

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

About this study

Official title: 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

Conditions: Renal Cell Cancer
Being tested: Pembrolizumab Pre-Resection, Surgical Resection, Pembrolizumab Post-Resection
Medical subject headings: Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pembrolizumab Pre-ResectionDrug
Also called KEYTRUDA®, MK-3475
200 mg administered by IV, once every 3-week cycle for a maximum of 2 cycles
Surgical ResectionProcedure or surgery
Standard of care surgical resection of RCC tumor
Pembrolizumab Post-ResectionDrug
Also called KEYTRUDA®, MK-3475
200 mg administered by IV, once every 3-week cycle for a maximum of 17 cycles

Study groups in NCT02212730
Study group	Role	What they receive
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. Receives: Drug: Pembrolizumab Pre-Resection; Procedure: Surgical Resection; Drug: Pembrolizumab Post-Resection
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. Receives: Procedure: Surgical Resection; Drug: Pembrolizumab Post-Resection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 7

Secondary outcomes (5)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Dec 20145 Jul 2019

First posted8 Aug 2014 (estimated)
Study start3 Dec 2014
Primary completion5 Jul 2019
Study completion5 Jul 2019

Why it stopped: Terminated early due to low enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Renal Cell CancerStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02212730
Sponsor's protocol ID: 3475-031
Other IDs: 2014-002526-12, MK-3475-031, KEYNOTE-031, 2014
Status last verified: Jun 2020
First submitted: 6 Aug 2014
Last updated: 16 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia

All Renal Cell Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02212730
Acronym / sponsor ID: 3475-031
Conditions: Renal Cell Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated early due to low enrollment
Enrolment: 10 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 3 Dec 2014 (actual)
Primary completion: 5 Jul 2019 (actual)
Study completion: 5 Jul 2019 (actual)
First posted: 8 Aug 2014 (estimated)
Results: Posted 16 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Neoadjuvant Pembrolizumab + RCC Resection	Experimental	Drug: Pembrolizumab Pre-Resection, Procedure: Surgical Resection, Drug: Pembrolizumab Post-ResectionParticipants 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	Procedure: Surgical Resection, Drug: Pembrolizumab Post-ResectionParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (20 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pembrolizumab Pre-ResectionAlso: KEYTRUDA®, MK-3475200 mg administered by IV, once every 3-week cycle for a maximum of 2 cycles	Drug	Neoadjuvant Pembrolizumab + RCC Resection
Surgical ResectionStandard of care surgical resection of RCC tumor	Procedure or surgery	Neoadjuvant Pembrolizumab + RCC Resection, RCC Resection
Pembrolizumab Post-ResectionAlso: KEYTRUDA®, MK-3475200 mg administered by IV, once every 3-week cycle for a maximum of 17 cycles	Drug	Neoadjuvant Pembrolizumab + RCC Resection, RCC Resection

Primary outcome

Number of Participants With an Adverse Event (AE) During the Neoadjuvant Pembrolizumab Regimen
Time frame: Up to Week 16
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.
Number of Participants Who Discontinued Treatment Due to an Adverse Event
Time frame: Up to 56 weeks
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.
Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral CD3+ Lymphocytic Infiltration
Time frame: Baseline and Week 7
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.
Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral CD8+ Lymphocytic Infiltration
Time frame: Baseline and Week 7
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.
Number of Participants Treated With Neoadjuvant Pembrolizumab With a 2-fold or Greater Change From Baseline in Intratumoral FoxP3+ Lymphocytic Infiltration
Time frame: Baseline and Week 7
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.

5 secondary outcomes

Change From Baseline in Levels of Gene Expression of Immune Modulatory Receptors in Tumors of Participants Treated With Neoadjuvant Pembrolizumab
Time frame: Baseline and Week 7
Change From Baseline in Number of T Cells in Tumors of Participants Treated With Neoadjuvant Pembrolizumab
Time frame: Baseline and Week 7
Change From Baseline in Number of Activated T Cells in Peripheral Blood of Participants Treated With Neoadjuvant Pembrolizumab
Time frame: 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
Time frame: 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
Time frame: Baseline and Week 7

Results and safety

Results posted to the registry on 16 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Neoadjuvant Pembrolizumab + RCC Resection	6	4
RCC Resection	4	3

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

Time frame: Up to Week 16. Count of participants. Unit: Participants

Measure	Neoadjuvant Pembrolizumab + RCC Resection n = 4
Value	4

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

Primary outcome: Number of Participants Who Discontinued Treatment Due to an Adverse Event

Time frame: Up to 56 weeks. Count of participants. Unit: Participants

Measure	Neoadjuvant Pembrolizumab + RCC Resection n = 4	RCC Resection n = 1
During neoadjuvant pembrolizumab	0	0
During post-RCC resection pembrolizumab	1	0

Population analysed: 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.

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

Time frame: Baseline and Week 7. Count of participants. Unit: Participants

Measure	Neoadjuvant Pembrolizumab + RCC Resection n = 4
Value	1

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

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

Time frame: Baseline and Week 7. Count of participants. Unit: Participants

Measure	Neoadjuvant Pembrolizumab + RCC Resection n = 4
Value	1

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

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 77 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Neoadjuvant Pembrolizumab + RCC Resection	1 of 4 (25%)	4 of 4 (100%)	0 of 6
Neoadjuvant Pembrolizumab+Resection+Post-Surgery Pembrolizumab	1 of 1 (100%)	1 of 1 (100%)	0 of 1
SOC RCC Resection	0 of 3 (0%)	0 of 3 (0%)	1 of 4
RCC Resection + Post-Resection Pembrolizumab	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Related trials for Renal Cell Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
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Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pembrolizumab Pre-Resection, Surgical Resection and Pembrolizumab Post-Resection in people with Renal Cell Cancer, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With an Adverse Event (AE) During the Neoadjuvant Pembrolizumab Regimen (time frame: Up to Week 16). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02212730.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.