Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Patients also receive hypofractionated RT over 5 fractions for 14 days.

Patients receive pembrolizumab as in Cohort I. Patients also receive conventionally fractionated RT over 30 fractions for 52 weeks.

Hypofractionated Radiation Therapy

Laboratory Biomarker Analysis

Radiation Therapy

Terence Friedlander

This randomized phase II trial studies how well radiation therapy and pembrolizumab work in treating patients with urothelial bladder cancer that is restricted to the site of origin, without evidence of spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving radiation therapy and pembrolizumab may work better in treating urothelial bladder cancer.

PRIMARY OBJECTIVES:

I. To determine the maximally tolerated doses of hypofractionated and conventionally fractionated radiation therapy in combination with pembrolizumab and to generate an estimate of the efficacy of this regimen. (Safety Lead-in) II. To estimate the clinical complete response (CR) rate of the primary irradiated tumor in patients receiving radiotherapy and pembrolizumab. (Dose Expansion Cohort)

SECONDARY OBJECTIVES:

I. To estimate the local control rate at 6 and 12 months in each study arm. II. To estimate the distant metastases free survival at 6 and 12 months in each study arm.

III. To estimate progression free survival at 6 and 12 months in each study arm.

IV. To estimate disease-specific survival at 6 and 12 months in each study arm. V. To determine the safety of combining radiotherapy with pembrolizumab in each study arm in the dose expansion phase.

TERTIARY OBJECTIVES:

I. To assess peripheral and tumor-based biomarkers of response and resistance. II. To define the treatment-induced effects on circulating immune cells. III. To explore the remodeling of circulating T cell repertoire.

OUTLINE: Patients are randomized to 1 of 2 cohorts.

COHORT I: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. Patients also receive hypofractionated radiation therapy (RT) over 5 fractions for 14 days.

COHORT II: Patients receive pembrolizumab as in Cohort I. Patients also receive conventionally fractionated RT over 30 fractions for 52 weeks.

After completion of study treatment, patients are followed up at 30 days and then every 12 weeks for up to 24 months.

Radiation Therapy and Pembrolizumab in Treating Patients With Localized Urothelial Bladder Cancer

A Phase II Study of Radiation Therapy and Pembrolizumab in Patients With Localized Urothelial Bladder Cancer That Are Ineligible or Refusing Chemotherapy

A complete response will be defined as the absence of visible tumor endoscopically (cystoscopically) and the absence of histologic evidence of disease if a biopsy is performed.

A cCR rate will be defined at week 12 after the initiation of study therapy as no residual muscle-invasive disease (=\< T1) on cystoscopy. This rate will be summarized using descriptive statistics. The point estimate of cCR rate will be obtained with its 95% confidence intervals.

Safety will be summarized using descriptive statistics.

DSS will be compared between two arms by the stratified log-rank test.

DMFS will be compared between two arms by the stratified log-rank test.

Safety and tolerability in all phases will be summarized by maximum toxicity grade for each study arm. The toxicity grade for laboratory data will be calculated using CTCAE version (v)4.3 and the lab data will be summarized according to the subjects baseline grade and maximum grade for each course of therapy. All treatment related adverse events will be graded using National Cancer Institute CTCAE v4.3 and will be recorded and listed.

The point estimate of LC rate will be summarized descriptively at each specified time point from 6-12 months after therapy using descriptive statistics with 95% confidence interval for each arm.

PFS will be compared between two arms by the stratified log-rank test.

Merck Sharp & Dohme LLC

University of California, San Francisco

Antibodies

Immunomodulating Agents

Nivolumab

Relatlimab

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

Immunologic Factors

Patients in Cohort A, Arm I receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI scans throughout the trial.

Patients in Cohort A, Arm II receive nivolumab IV over 30 minutes and relatlimab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI scans throughout the trial.

Patients in Cohort B, Arm III receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI scans throughout the trial.

Patients in Cohort B, Arm IV undergo ctDNA surveillance consisting of collection of tissue and blood during screening and collection of blood only on study and during follow up. Patients who convert to ctDNA(+) during surveillance then receive nivolumab IV over 30 minutes and relatlimab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans throughout the trial.

Biospecimen Collection

cfDNA or ctDNA Measurement

Computed Tomography

Magnetic Resonance Imaging

Quality-of-Life Assessment

Questionnaire Administration

Site Public Contact

Tyler Stewart

Sarmad Sadeghi

Mamta Parikh

Gregory A. Masters

Brian H. Ramnaraign

Bryan A. Faller

David VanderWeele

Natalie Reizine

Randy F. Sweis

Nicklas R. Pfanzelter

Melissa A. Reimers

Tareq Salous

Joseph J. Merchant

Joshua Lukenbill

Richard L. Deming

Brian T. Halbert

Sarah J. Sinclair

Brendan Connell

Elie G. Dib

Daniel Almquist

John C. Henegan

Kushal Naha

Jay W. Carlson

Harshraj Leuva

Douglas J. Weckstein

David H. Aggen

Robert S. Alter

Biren Saraiya

Matthew D Galsky

This phase II/III trial examines whether patients who have undergone surgical removal of bladder, but require an additional treatment called immunotherapy to help prevent their bladder cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. In this study, a blood test is used to measure ctDNA and see if there is still cancer somewhere in the body after surgery and if giving a treatment will help eliminate the cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and relatlimab, can help the body's immune system to attack the cancer, and can interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if ctDNA measurement in blood can better identify patients that need additional treatment, if treatment with nivolumab prolongs patients' life and whether the additional immunotherapy treatment with relatlimab extends time without disease progression or prolongs life of bladder cancer patients who have undergone surgical removal of their bladder.

PRIMARY OBJECTIVES:

I. To compare the ctDNA clearance proportion (i.e., ctDNA positive \[+\] --\> ctDNA negative \[-\]) at 12 weeks in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab (phase 2 portion).

II. To compare overall survival in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab (phase 3 portion).

III. To compare disease-free survival in patients enrolled in Cohort B randomized to immediate treatment with nivolumab to those randomized to surveillance with subsequent treatment with nivolumab only upon converting to ctDNA(+)

SECONDARY OBJECTIVES:

I. To compare disease-free survival in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab.

II. To define the association between ctDNA clearance and disease-free survival and overall survival for Cohort A patients.

III. To compare overall survival in patients enrolled in Cohort B randomized to immediate treatment with nivolumab to those randomized to surveillance with subsequent treatment with nivolumab only upon converting to ctDNA(+).

IV. To determine the lead time from a ctDNA(+) assay to radiographic recurrence in patients initially ctDNA(-) post-definitive surgery enrolled in Cohort B.

V. To estimate the proportion of Cohort B patients on Arm 4 who become ctDNA(+) and receive nivolumab.

VI. To compare the cumulative incidence of Cohort B patients who become ctDNA(+) between Arms 3 and 4.

VII. To determine the safety of adjuvant nivolumab plus relatlimab.

EXPLORATORY OBJECTIVES:

I. To explore the kinetics of quantitative ctDNA levels (mean number of tumor molecules observed per mL of plasma or MTM/ml) over time and the association between ctDNA kinetics and time-to-event outcomes.

II. To estimate the costs and value of care in patients with a ctDNA(+) assay post-cystectomy treated with adjuvant nivolumab versus nivolumab + relatlimab.

III. To estimate the costs and value of care in patients with a ctDNA(-) assay post-cystectomy treated with adjuvant nivolumab versus surveillance with subsequent treatment with nivolumab at the time of conversion to ctDNA(+).

QUALITY OF LIFE OBJECTIVES:

I. Within each cohort, to compare quality-adjusted survival among randomized arms using European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L).

II. Within Cohort B, to compare overall quality of life (QOL) as measured by the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) between baseline and 42 months (calculated as the area under the curve) among randomized arms.

III. Within each cohort, to compare overall QOL as measured by the EORTC QLQ-C30 at each time point among randomized arms.

IV. Within each cohort, to compare bladder cancer-specific QOL as measured by the EORTC Bladder Cancer Muscle-Invasive 30 Questionnaire (QLQ-BLM30) at each time point among randomized arms.

V. Within each cohort, to compare patient-reported fatigue as measured by Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue at each time point among randomized arms.

VI. Within each cohort, to compare patient-reported fear of cancer recurrence as measured by the Fear of Cancer Recurrence Inventory (FCRI)-Short Form at each time point among randomized arms.

OUTLINE: Patients are assigned to 1 of 2 cohorts based on ctDNA results.

COHORT A: Patients who are ctDNA(+) are randomized to 1 of 2 arms:

ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) scans throughout the trial.

ARM II: Patients receive nivolumab IV over 30 minutes and relatlimab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI scans throughout the trial.

COHORT B: Patients who are ctDNA(-) are randomized to 1 of 2 arms:

ARM III: Patients receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI scans throughout the trial.

ARM IV: Patients undergo ctDNA surveillance consisting of collection of tissue and blood during screening and collection of blood only on study and during follow up. Patients who convert to ctDNA(+) during surveillance then receive nivolumab IV over 30 minutes and relatlimab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans throughout the trial.

After completion of study treatment, patients are followed up at weeks 60, 72, 84, 96, 120, 144, 196, and 248.

Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder for Bladder Cancer Treatment, MODERN Study

MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcer

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Will be determined for each treatment arm as the number of patients who are ctDNA(-) after 12 weeks of treatment divided by the total number of patients on the treatment arm. Patients who do not have a 12-week ctDNA result will be deemed to be ctDNA(+). The comparison of the proportions of patients who are ctDNA(-) after 12 weeks of treatment between the two arms will be performed with a chi-square test.

The analysis will be performed using a stratified log-rank test that uses the specified stratification variables. An additional analysis will be perform using a stratified Cox regression model to generate the point estimate and 90% confidence interval for the hazard ratio (HR) (comparing Arm 2 to Arm 1).

A stratified Cox model (using the randomization stratification variables will be used to generate a 90% confidence interval (CI) for the HR. If the 90% confidence interval (CI) does not contain 1.39, Arm 4 (surveillance with ctDNA serial testing to determine whether patient is treated with nivolumab) will be deemed to be non-inferior to treating patients immediately with nivolumab.

Will be determined for each treatment arm as the number of patients who are ctDNA(-) after 12 weeks of treatment divided by the total number of patients on the treatment arm. Patients who do not have a 12-week ctDNA result will be deemed to be ctDNA(+).

If the trial does not continue to phase III, OS will be a secondary endpoint.

This will be a secondary endpoint for the phase III trial, if completed, or for the phase II trial if the phase III trial is not performed.

Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Adverse events (AEs) will be summarized with frequencies and relative frequencies. The maximum grade for an AE will be recorded for each patient by treatment arm. The number (percent) of patients that experience each observed adverse event will be summarized by treatment arm. In addition, the proportion of patients that experience a grade 3+, grade 4+, and grade 5 adverse event will be summarized as the number and percent of patients by treatment arm. The primary summary will be regardless of attribution.

Will be assessed using CTCAE v5.0. Adverse events will be summarized with frequencies and relative frequencies. The maximum grade for an AE will be recorded for each patient by treatment arm. The number (percent) of patients that experience each observed adverse event will be summarized by treatment arm. In addition, the proportion of patients that experience a grade 3+, grade 4+, and grade 5 adverse event will be summarized as the number and percent of patients by treatment arm. The primary summary will be regardless of attribution.

National Cancer Institute (NCI)

Hydronephrosis

Urethral Neoplasms

Ureteral Neoplasms

Pelvic Neoplasms

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urethral Diseases

Urologic Diseases

Male Urogenital Diseases

Kidney Diseases

Ureteral Diseases

Urethral Cancer

Antibodies, Monoclonal

Cisplatin

Durvalumab

Tremelimumab

Ipilimumab

Patients receive tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1 of weeks 1 and 4. Beginning 4-6 weeks after the last infusion, patients undergo cystectomy with pelvic lymph node dissection surgery.

Undergo cystectomy with pelvic lymph node dissection

Therapeutic Conventional Surgery

Jianjun Gao

This pilot phase I trial studies the side effects of durvalumab and tremelimumab in treating patients with muscle-invasive, high-risk urothelial cancer that cannot be treated with cisplatin-based therapy before surgery. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.

PRIMARY OBJECTIVES:

I. To evaluate the safety and tolerability of durvalumab and tremelimumab in patients with muscle-invasive, high-risk bladder cancer who are ineligible for neoadjuvant cisplatin-containing chemotherapies.

SECONDARY OBJECTIVES:

I. To assess immunologic/molecular responses (e.g. peripheral blood cluster of differentiation \[CD\] 4+inducible T-cell co-stimulator \[ICOS\]+ T cells) to durvalumab and tremelimumab in patients with muscle-invasive, high-risk bladder cancer who are ineligible for neoadjuvant cisplatin-containing chemotherapies.

II. To evaluate pathologic T0 rate after neoadjuvant treatment with durvalumab and tremelimumab in patients with muscle-invasive, high-risk bladder cancer comparing to historical data (about 10% in patients with high-risk disease).

III. To evaluate relapse-free survival (RFS) and overall survival (OS).

OUTLINE:

Patients receive tremelimumab intravenously (IV) over 1 hour and durvalumab IV over 1 hour on day 1 of weeks 1 and 4. Beginning 4-6 weeks after the last infusion, patients undergo cystectomy with pelvic lymph node dissection surgery.

After completion of study treatment, patients are followed up at 90 days, and then every 3 months for up 1 year.

Durvalumab and Tremelimumab in Treating Patients With Muscle-Invasive, High-Risk Urothelial Cancer That Cannot Be Treated With Cisplatin-Based Therapy Before Surgery

A Pilot Pre-Surgical Study Evaluating Anti-PD-L1 Antibody (Durvalumab) Plus Anti-CTLA-4 (Tremelimumab) in Patients With Muscle-Invasive, High-Risk Urothelial Carcinoma Who Are Ineligible for Cisplatin-Based Neoadjuvant Chemotherapy

M.D. Anderson Cancer Center

Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days (2 weeks) for up to 14 courses (6 months) in the absence of disease progression or unacceptable toxicity. Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9.

Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9.

Radiation

Ulka N. Vaishampayan, M.D.

This phase II trial studies how well nivolumab works with radiation therapy in treating patients with urothelial bladder cancer that has spread from its original site of growth to nearby tissues or lymph nodes and are ineligible for chemotherapy. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab and radiation therapy may work better in treating patients with urothelial bladder cancer.

PRIMARY OBJECTIVES:

I. To compare the 12-month rate of progression-free survival (PFS) achieved with the combination of nivolumab, a programmed death (PD-1) inhibitor, and radiation therapy in localized/locally advanced urothelial cancer patients, who are chemotherapy ineligible, to a historical control reference 12-month PFS rate.

SECONDARY OBJECTIVES:

I. To assess the toxicity of concurrent nivolumab and radiation therapy in urothelial cancer.

II. To determine overall response rate (ORR). III. To determine metastasis-free survival (MFS). IV. To determine overall survival (OS). V. To evaluate the quality of life and bladder functioning during and after the therapy.

VI. To explore the relationships of PD-1 expression, PDL-1 expression, and the Th1/Th2 cytokine ratio to clinical outcomes (response, PFS, MFS, and OS).

OUTLINE:

Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 14 days (2 weeks) for up to 14 courses (6 months) in the absence of disease progression or unacceptable toxicity. Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9.

After completion of study treatment, patients are followed up every 3 months for 12 months.

Nivolumab and RT in Treating Patients With Localized/Locally Advanced Urothelial Bladder Cancer Ineligible for Chemo

Phase II Trial of Concurrent Nivolumab in Urothelial Bladder Cancer With Radiation Therapy in Localized/Locally Advanced Disease for Chemotherapy Ineligible Patients [NUTRA]

PFS distribution will be summarized with the Kaplan-Meier (K-M) survivorship estimate. A graph of the K-M curve for PFS will be generated along with the Hall-Wellner 90% confidence band, and a display of the number of patients at risk at several time points, below the X-axis. Summary statistics (12-month PFS rate, median PFS, etc.) will be calculated from the K-M life table, each one with its respective 90% confidence interval (CI).

ORR will be estimated among all patients. Frequency distributions of best response will be generated. The point estimate of the ORR will be computed, along with its 95% (Wilson type) CI.

MFS will be calculated as a rate at 1 year with a 90% confidence interval from the K-M life tables.

Summary statistics of OS will be calculated from the K-M life tables. K-M graphs of the censored OS distributions will also be generated.

The QOL score will be measured pre therapy, during therapy and after therapy to compare the changes.

PD-1 status will be checked on pre-therapy tumor tissue and will be correlated with the primary endpoint. Also, the PDL-1 status will be checked on pre-therapy tumor tissue and will be correlated with the primary endpoint.

The continuous markers (e.g., tumor infiltrating lymphocyte \[TIL\]s, Th1/Th2 cytokine ratio, etc.) will be summarized with standard descriptive statistics. These descriptive analyses of the serum markers will be performed for each time point at which the each marker is determined. Response (CR/PR vs not) will be modeled as a function of a dichotomized version of pre-study the continuous (ungrouped) markers (e.g., TILs from tissue, and the Th1/Th2 cytokine ratio from serum). The statistical goal of these exploratory analyses is to obtain the point and 95% CI estimates of the OR, and to simply determine the direction and approximate magnitude of these associations for use in planning a subsequent study. Censored PFS will be modeled as a function of a dichotomized version of the continuous (ungrouped) markers (e.g., TILs from tissue, and the Th1/Th2 cytokine ratio using Cox modelling strategy.

Bristol-Myers Squibb

Barbara Ann Karmanos Cancer Institute

Principal Investigator

Given IV

Nivolumab: Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days (2 weeks) for up to 14 courses (6 months) in the absence of disease progression or unacceptable toxicity. Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9.

Radiation: Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9.

Treatment (Nivolumab, Radiation Therapy)

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

ECOG Performance Status Scale. Grade 0 to 5. 0=Normal activity, 1=Symptoms but ambulatory, 2=In bed \<50% of the time, 3=In bed \>50% of the time, 4=100% bedridden, 5=Dead

Performance Status

T2Nx: Clinically main tumor invades muscularis propria, Cancer in lymph nodes cannot be measured.

pT2: Pathologically invades muscularis propria

pT2N1: Pathologically invades muscularis propria with a single node in the true pelvis

pT2Nx: Pathologically tumor invades muscularis propria, Cancer in lymph nodes not measurable.

pT2b: Pathologically invades the outer half of the muscularis propria.

pT4: Pathologically directly invades into adjacent structures.

Pathologic stage T2 -T4 disease including T4a and 4b T2: tumor has spread to the muscle layer. T3: tumor invades the peripelvic fat, renal parenchyma, or into the fat around the ureter.

T4: tumor invades nearby organs or outer layer of fat on the kidney. T4a: tumor invades the prostate, seminal vesicles, uterus, or vagina T4b: tumor has spread to the pelvic wall or the abdominal wall

Pathological stage

Prior Bacillus Calmette-Guerin (BCG) Therapy

Prior Chemotherapy

Nitin Vaishampayan, MD

Progression-free Survival (PFS)

Overall Response Rate (ORR)

Metastasis-free Survival (MFS)

Overall Survival (OS)

Quality of Life (QOL) and Bladder Functioning Questionnaires Assessment

PD-1 <5

PD-1 =>5

PD-L1 <5

PD-L1 =>5

Those patients that had pre-therapy tumor tissue analyzed for PD-1 and PD-L1 (18 participants total).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiation Therapy and Pembrolizumab in Treating Patients With Localized Urothelial Bladder Cancer	NCT03419130	Infiltrating Bl... Stage II Bladde... Stage III Bladd...	Hypofractionate... Laboratory Biom... Pembrolizumab Radiation Thera...	18 Years -	University of California, San Francisco
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder for Bladder Cancer Treatment, MODERN Study	NCT05987241	Muscle Invasive... Stage II Bladde... Stage III Bladd... Stage IV Bladde...	Biospecimen Col... cfDNA or ctDNA ... Computed Tomogr... Magnetic Resona... Nivolumab Quality-of-Life... Questionnaire A... Relatlimab	18 Years -	National Cancer Institute (NCI)
Durvalumab and Tremelimumab in Treating Patients With Muscle-Invasive, High-Risk Urothelial Cancer That Cannot Be Treated With Cisplatin-Based Therapy Before Surgery	NCT02812420	Hydronephrosis Infiltrating Bl... Infiltrating Bl... Infiltrating Bl... Infiltrating Re... Renal Pelvis Ur... Stage II Bladde... Stage II Renal ... Stage II Ureter... Stage II Urethr... Stage III Bladd... Stage III Renal... Stage III Urete... Stage III Ureth... Stage IV Renal ... Stage IV Ureter... Stage IV Urethr... Ureter Urotheli... Urethral Urothe...	Durvalumab Therapeutic Con... Tremelimumab	18 Years -	M.D. Anderson Cancer Center
Radiation Therapy and Pembrolizumab in Treating Patients With Localized Urothelial Bladder Cancer	NCT03419130	Infiltrating Bl... Stage II Bladde... Stage III Bladd...	Hypofractionate... Laboratory Biom... Pembrolizumab Radiation Thera...	18 Years -	University of California, San Francisco
Nivolumab and RT in Treating Patients With Localized/Locally Advanced Urothelial Bladder Cancer Ineligible for Chemo	NCT03421652	Stage II Bladde... Stage III Bladd... Stage IV Bladde...	Nivolumab Radiation	18 Years -	Barbara Ann Karmanos Cancer Institute

Spots Global Cancer Trial Database for stage ii bladder urothelial carcinoma ajcc v6 and v7