Urothelial CarcinomaPhase 2NCT02500121
Testing the PD-1 Inhibitor Pembrolizumab as Maintenance Therapy After Initial Chemotherapy in Metastatic Bladder Cancer
A Phase 2 study testing Pembrolizumab in people with Urothelial Carcinoma and Bladder Cancer, run by Matthew Galsky at 28 sites in United States.
Trial summary
This is a multi-institutional, randomized, placebo controlled, double-blinded phase II trial of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients with metastatic urothelial cancer who have achieved at least stable disease on first-line chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma, Bladder Cancer
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 28 sitesUnited States
- Study dates
- 11 Nov 2015to 1 Jan 2021
- Phase
- Phase 2
- 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
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status (PS) of ≤ 1 within fourteen days of registration for protocol therapy.
- Histological or cytological evidence of urothelial cancer of the bladder, urethra, ureter, or renal pelvis. Differentiation with variant histologies (e.g., squamous cell differentiated) will be permitted provided that the predominant histology is urothelial carcinoma.
- Metastatic and/or unresectable (cT4b) disease
- Must have achieved an objective response (CR/PR) or stable disease (SD) after 4 to 6 cycles of standard first-line platinum-based chemotherapy for mUC (e.g., as per NCCN guidelines). Able to commence study treatment within 2 to 6 weeks of receiving last dose of first-line chemotherapy.
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- All subjects must have adequate archival tissue available prior to registration (i.e., at least 20 unstained slides or paraffin block). If acceptable archival tissue is not available, the subject must be willing to consent to providing a core or excisional biopsy for research prior to registration for protocol therapy. If archival tissue is not available and there are no sites amenable to biopsy, enrollment must be discussed with the sponsor-investigator on a case by case basis.
- Female subjects of childbearing potential must have a negative serum pregnancy within three days prior to registration for protocol therapy
- Sexually active, pre-menopausal women of childbearing potential must be willing to use an adequate method of contraception or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study drug. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > one year.
- Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug.
Who cannot join
- More than one line of prior chemotherapy for metastatic or locally advanced disease, with the following exception:
- Prior neoadjuvant/adjuvant chemotherapy will not count as line of therapy if completed greater than 12 months prior to initiation of chemotherapy regimen for metastatic or unresectable disease.
- Current or past participation in a study of an investigational agent or using an investigational device within four weeks of registration for protocol therapy.
- A diagnosis of immunodeficiency or is receiving treatment with systemic steroid therapy or any other form of immunosuppressive therapy within seven days prior to registration for protocol therapy.
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within two weeks prior to registration for protocol therapy. Note: If the subjects have undergone major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting protocol therapy.
- A known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
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- A known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to registration for protocol therapy and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least seven days prior to registration for protocol therapy.
- Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has evidence of active, non-infectious pneumonitis.
- Has a history of interstitial lung disease.
- An active infection requiring systemic therapy.
- A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening period through 120 days after the last dose of protocol therapy.
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). Examples include nivolumab, MPDL3280, etc.
- A known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- A known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Receipt of a live vaccine within 30 days prior to registration for protocol therapy.
- Unresolved toxicity (i.e., > Grade 1 or above baseline) due to previously administered agents. Exception includes: subjects with ≤ Grade 2 neuropathy are eligible for the study.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
University of Maryland
Baltimore, Maryland, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Medical University of South Carolina
Charleston, South Carolina, 29425
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Henry Ford Health System
Detroit, Michigan, 48202
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
University of Florida
Gainesville, Florida, 32610
IU Health Goshen Center for Cancer Care
Goshen, Indiana, 46526
The John Theuer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
IU Health Central Indiana Cancer Center
Indianapolis, Indiana, 46219
Community Regional Cancer Care
Indianapolis, Indiana, 46256
University of Southern California
Los Angeles, California, 90033
University of Minnesota
Minneapolis, Minnesota, 55455
Community Healthcare System
Munster, Indiana, 46321
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Tisch Cancer Institute at Mount Sinai Medical Center
New York, New York, 10029
Virginia Oncology Associates
Norfolk, Virginia, 23502
GU Cancer Research Network, LLC
Omaha, Nebraska, 68130
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Arizona at Dignity Health St. Joseph's
Phoenix, Arizona, 85004
University of Rochester Medical Center
Rochester, New York, 14642
Huntsman Cancer Institute University of Utah
Salt Lake City, Utah, 84112
Washington University: Siteman Cancer Center
St Louis, Missouri, 63110
Georgetown University
Washington D.C., District of Columbia, 20057
About this study
Official title: A Randomized, Double-blinded, Phase II Study of Maintenance Pembrolizumab Versus Placebo After First-Line Chemotherapy in Patients With Metastatic Urothelial Cancer: Hoosier Cancer Research Network GU14-182
This is a multi-institutional, randomized, placebo controlled, double-blinded phase II trial of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients with metastatic urothelial cancer who have achieved at least stable disease on first-line chemotherapy.
Read the detailed description
OUTLINE: This is a multi-center trial.
Eligible subjects will be 1:1 randomized to placebo (Control Arm A) and pembrolizumab (Experimental Arm B). Stratification factors for randomization: presence of visceral metastatic disease (lung, liver, or bone or other organs vs. lymph node only) at the time of initiation of first-line chemotherapy, and response to first-line chemotherapy (CR/PR vs. SD. Subjects who progress on placebo will be assessed to determine if they are eligible to cross over to unblinded treatment with pembrolizumab.
INVESTIGATIONAL TREATMENT:
For Control Arm A, commercially available normal saline will be used as the placebo. No active placebo drug will be mixed with the normal saline.
For Experimental Arm B, pembrolizumab (or placebo), 200 mg intravenous infusion (IV) every 3 weeks for up to 12 months, or until progressive disease (PD) or unacceptable toxicity.
The following required laboratory values must be obtained within fourteen days prior to registration for protocol therapy:
Hematopoietic:
- Absolute neutrophil count (ANC) ≥1,500 /mcL
- Platelets ≥100,000 / mcL
- Hemoglobin ≥8.5 g/dL
Renal:
- Creatinine ≤1.5x ULN OR
- Measured or calculated creatinine clearance ≥30 mL/min for subject with creatinine levels >1.5x institutional ULN
- GFR can also be used in place of creatinine or CrCl
Hepatic:
- Serum total bilirubin ≤ 1.5 X ULN OR
- Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
- AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subject with liver metastases
Coagulation:
- International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN. If subject is on anticoagulant therapy, PT or PTT must be within therapeutic range of intended use of anticoagulants.
- Conditions
- Urothelial Carcinoma, Bladder Cancer
- Being tested
- Placebo, Pembrolizumab
- Keywords
- Pembrolizumab, PD-1 Inhibitor
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Normal saline
PembrolizumabDrug
Pembrolizumab, 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or for up to 24 months
| Study group | Role | What they receive |
|---|---|---|
| Control Arm A | Placebo comparator | Commercially available normal saline will be used as the placebo. No active placebo drug will be mixed with the normal saline. Treatment will continue, in the absence of prohibitive toxicities or disease progression, for up to 24 months. Receives: Other: Placebo |
| Experimental Arm B | Experimental | Pembrolizumab, 200mg IV every 3 weeks. Treatment will continue, in the absence of prohibitive toxicities or disease progression, for up to 24 months. Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Measured at the time from randomization to death or progression, depending on which occurs first, as per immune-related RECIST (irRECIST). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: Calculated after a median follow-up time of 12.9 months
Secondary outcomes (5)
6-month PFS as Per irRECIST
Probability that subjects remain alive and progression free at 6 months post randomization per irRECIST criteria. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Six months after randomization
Number of Subjects With Adverse Events as a Measure of the Safety and Tolerability of Pembrolizumab
Percentage of subjects with treatment-emergent grade 3-4 toxicities, as per Common Terminology Criteria for Adverse Events (CTCAE) v 4.0
Measured: Every 3 weeks beginning with C1D1 for up to 24 months
Objective Response Rate (ORR) Assessment of Subjects on Maintenance Pembrolizumab vs Placebo
The objective response rate is the percentage of all subjects with confirmed PR or CR according to RECIST, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment)
Complete Response per RECIST 1.1 is defined as the disappearance of all target and non-target lesions and the reduction in size of any pathologic lymph nodes to <10mm in the absence of the appearance of any new lesions.
Partial Response per RECIST 1.1 is defined by at least a 30% decrease in the sum of the diameters of target lesions when compared to baseline, no equivocal progression of non-target disease and no appearance of new lesions.
Measured: Response assessed every 12 weeks from the date of randomization to the date of documented disease progression or date of death, whichever occurs first, assessed for up to a maximum of 104 weeks (24 months)
ORR Assessment of Subjects Receiving Pembrolizumab After Progressing on Placebo
The objective response rate is the percentage of all subjects with confirmed PR or CR according to RECIST, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment)
Complete Response per RECIST 1.1 is defined as the disappearance of all target and non-target lesions and the reduction in size of any pathologic lymph nodes to <10mm in the absence of the appearance of any new lesions.
Partial Response per RECIST 1.1 is defined by at least a 30% decrease in the sum of the diameters of target lesions when compared to baseline, no equivocal progression of non-target disease and no appearance of new lesions.
Measured: Every 12 weeks from the first treatment on the crossover to the date of documented disease progression, per irRECIST 1.1, assessed for up to a maximum of 104 weeks (24 months)
Median Overall Survival (OS) Time in Subjects Treated With Pembrolizumab vs Placebo
Median time from randomization until death from any cause in subjects treated with pembrolizumab vs placebo.
Measured: From randomization until death from any cause. Reported after a median follow-up of 12.9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study start11 Nov 2015
- Primary completion1 Jul 2019
- Study completion1 Jan 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthew Galsky
- Sponsor type
- University, hospital or other
- Collaborators
- Hoosier Cancer Research Network, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Matthew Galsky, Hoosier Cancer Research Network
- Investigators
- Matthew Galsky, M.D., Study chair, Hoosier Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500121
- Sponsor's protocol ID
- HCRN GU14-182
- Status last verified
- Sep 2022
- First submitted
- 8 Jul 2015
- Last updated
- 30 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Galsky MD, Mortazavi A, Milowsky MI, George S, Gupta S, Fleming MT, Dang LH, Geynisman DM, Walling R, Alter RS, Kassar M, Wang J, Gupta S, Davis N, Picus J, Philips G, Quinn DI, Haines GK 3rd, Hahn NM, Zhao Q, Yu M, Pal SK. Randomized Double-Blind Phase II Study of Maintenance Pembrolizumab Versus Placebo After First-Line Chemotherapy in Patients With Metastatic Urothelial Cancer. J Clin Oncol. 2020 Jun 1;38(16):1797-1806. doi: 10.1200/JCO.19.03091. Epub 2020 Apr 9.
PubMed 32271672
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Phase II Study of Maintenance Pembrolizumab Versus Placebo After First-Line Chemotherapy in Patients With Metastatic Urothelial Cancer: Hoosier Cancer Research Network GU14-182
- ClinicalTrials.gov ID
- NCT02500121
- Acronym / sponsor ID
- HCRN GU14-182
- Conditions
- Urothelial Carcinoma, Bladder Cancer
- Keywords
- Pembrolizumab, PD-1 Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Matthew GalskyUniversity, hospital or other
- Collaborators
- Hoosier Cancer Research Network, Merck Sharp & Dohme LLC
- Study start
- 11 Nov 2015 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Posted 30 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-institutional, randomized, placebo controlled, double-blinded phase II trial of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients with metastatic urothelial cancer who have achieved at least stable disease on first-line chemotherapy.
Detailed description
OUTLINE: This is a multi-center trial.
Eligible subjects will be 1:1 randomized to placebo (Control Arm A) and pembrolizumab (Experimental Arm B). Stratification factors for randomization: presence of visceral metastatic disease (lung, liver, or bone or other organs vs. lymph node only) at the time of initiation of first-line chemotherapy, and response to first-line chemotherapy (CR/PR vs. SD. Subjects who progress on placebo will be assessed to determine if they are eligible to cross over to unblinded treatment with pembrolizumab.
INVESTIGATIONAL TREATMENT:
For Control Arm A, commercially available normal saline will be used as the placebo. No active placebo drug will be mixed with the normal saline.
For Experimental Arm B, pembrolizumab (or placebo), 200 mg intravenous infusion (IV) every 3 weeks for up to 12 months, or until progressive disease (PD) or unacceptable toxicity.
The following required laboratory values must be obtained within fourteen days prior to registration for protocol therapy:
Hematopoietic:
- Absolute neutrophil count (ANC) ≥1,500 /mcL
- Platelets ≥100,000 / mcL
- Hemoglobin ≥8.5 g/dL
Renal:
- Creatinine ≤1.5x ULN OR
- Measured or calculated creatinine clearance ≥30 mL/min for subject with creatinine levels >1.5x institutional ULN
- GFR can also be used in place of creatinine or CrCl
Hepatic:
- Serum total bilirubin ≤ 1.5 X ULN OR
- Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
- AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subject with liver metastases
Coagulation:
- International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN. If subject is on anticoagulant therapy, PT or PTT must be within therapeutic range of intended use of anticoagulants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm A | Placebo comparator | Other: PlaceboCommercially available normal saline will be used as the placebo. No active placebo drug will be mixed with the normal saline. Treatment will continue, in the absence of prohibitive toxicities or disease progression, for up to 24 months. |
| Experimental Arm B | Experimental | Drug: PembrolizumabPembrolizumab, 200mg IV every 3 weeks. Treatment will continue, in the absence of prohibitive toxicities or disease progression, for up to 24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status (PS) of ≤ 1 within fourteen days of registration for protocol therapy.
- Histological or cytological evidence of urothelial cancer of the bladder, urethra, ureter, or renal pelvis. Differentiation with variant histologies (e.g., squamous cell differentiated) will be permitted provided that the predominant histology is urothelial carcinoma.
- Metastatic and/or unresectable (cT4b) disease
Key exclusion criteria (19 listed)
- More than one line of prior chemotherapy for metastatic or locally advanced disease, with the following exception:
- Current or past participation in a study of an investigational agent or using an investigational device within four weeks of registration for protocol therapy.
- A diagnosis of immunodeficiency or is receiving treatment with systemic steroid therapy or any other form of immunosuppressive therapy within seven days prior to registration for protocol therapy.
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within two weeks prior to registration for protocol therapy. Note: If the subjects have undergone major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting protocol therapy.
- A known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
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 |
|---|---|---|
| PlaceboNormal saline | Other | Control Arm A |
| PembrolizumabPembrolizumab, 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or for up to 24 months | Drug | Experimental Arm B |
Primary outcome
Progression-free Survival (PFS)
Time frame: Calculated after a median follow-up time of 12.9 months
Measured at the time from randomization to death or progression, depending on which occurs first, as per immune-related RECIST (irRECIST). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
5 secondary outcomes
6-month PFS as Per irRECIST
Time frame: Six months after randomization
Number of Subjects With Adverse Events as a Measure of the Safety and Tolerability of Pembrolizumab
Time frame: Every 3 weeks beginning with C1D1 for up to 24 months
Objective Response Rate (ORR) Assessment of Subjects on Maintenance Pembrolizumab vs Placebo
Time frame: Response assessed every 12 weeks from the date of randomization to the date of documented disease progression or date of death, whichever occurs first, assessed for up to a maximum of 104 weeks (24 months)
ORR Assessment of Subjects Receiving Pembrolizumab After Progressing on Placebo
Time frame: Every 12 weeks from the first treatment on the crossover to the date of documented disease progression, per irRECIST 1.1, assessed for up to a maximum of 104 weeks (24 months)
Median Overall Survival (OS) Time in Subjects Treated With Pembrolizumab vs Placebo
Time frame: From randomization until death from any cause. Reported after a median follow-up of 12.9 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32271672Galsky MD, Mortazavi A, Milowsky MI, George S, Gupta S, Fleming MT, Dang LH, Geynisman DM, Walling R, Alter RS, Kassar M, Wang J, Gupta S, Davis N, Picus J, Philips G, Quinn DI, Haines GK 3rd, Hahn NM, Zhao Q, Yu M, Pal SK. Randomized Double-Blind Phase II Study of Maintenance Pembrolizumab Versus Placebo After First-Line Chemotherapy in Patients With Metastatic Urothelial Cancer. J Clin Oncol. 2020 Jun 1;38(16):1797-1806. doi: 10.1200/JCO.19.03091. Epub 2020 Apr 9.
- Hoosier Cancer Research Network WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Matthew Galsky, M.D. study chair
Hoosier Cancer Research Network
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab in people with Urothelial Carcinoma and Bladder Cancer, run by Matthew Galsky at 28 sites in United States.
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 10 inclusion and 19 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: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 30 Sep 2022). 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?
Progression-free Survival (PFS) (time frame: Calculated after a median follow-up time of 12.9 months). 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 NCT02500121, which also lists 1 linked publication.
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 30 Sep 2022.