Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Nivolumab

Immune Checkpoint Inhibitors

Sunitinib

Tyrosine Kinase Inhibitors

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Patients in Arm A will receive bempegaldesleukin in combination with nivolumab.

Patients in Arm B will receive the Investigator's choice of either one of two treatment options.

bempegaldesleukin

sunitinib

nivolumab

cabozantinib

Study Director

The main purpose of this study is to compare the objective response rate (ORR) and overall survival (OS) of bempegaldesleukin (NKTR-214: BEMPEG) combined with nivolumab to that of tyrosine kinase inhibitor (TKI) monotherapy (sunitinib or cabozantinib) in IMDC intermediate- or poor-risk patients and IMDC all-risk patients with previously untreated advanced renal cell carcinoma (RCC).

A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)

A Phase 3 Randomized Open Label Study to Compare NKTR-214 Combined With Nivolumab to the Investigator's Choice of Sunitinib or Cabozantinib in Patients With Previously Untreated Advanced Renal Cell Carcinoma

ORR using modified Response Evaluation Criteria in Solid Tumors (mRECIST) 1.1 by Blinded Independent Central Review (BICR) in International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) All-risk patients and intermediate- or poor-risk patients.

ORR is defined as the proportion of enrolled participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR.

OS is defined as the time from date of first dose to the date of death from any cause. Patients without a date of death were censored at their last known alive date.

Progression-free survival is defined as the time between the date of randomization and the first date of documented tumor progression using mRECIST 1.1 per BICR or death due to any cause, whichever comes first.

Bristol-Myers Squibb

Nektar Therapeutics

Patients in Arm A will receive bempegaldesleukin in combination with nivolumab.

Bempegaldesleukin (NKTR-214) 0.006 mg/kg intravenous (IV) every 3 weeks (q3w) combined with nivolumab 360 mg IV q3w

Combination of Bempegaldesleukin + Nivolumab

Patients in Arm B will receive the Investigator's choice of either one of two treatment options.

Sunitinib 50 mg per orally (po) once daily for 4 weeks followed by 2 weeks off OR Cabozantinib 60 mg po once daily

Sunitinib or Cabozantinib

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Black or African American

Asian

American Indian or Alaska Native

Native Hawaiian or Other Pacific Islander

Not Reported

Other

Race/Ethnicity, Customized

Argentina

Singapore

United States

Russia

New Zealand

Brazil

Mexico

Australia

Chile

Peru

Region of Enrollment

KPS < 80

KPS >= 80

The Karnofsky Performance Status (KPS) scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities; For example: Score of 100 = Normal, no complaints, no evidence of disease. 80 = Normal activity with effort; some signs or symptoms of disease. 50 = Requires considerable assistance and frequent medical care. 30 = Severely disabled, hospitalization indicated. Death not imminent. 0 = Dead

Karnofsky Performance Status (KPS) Score

A total of 623 patients were randomized in the ITT International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) All-risk population, including 514 patients for the ITT I/P-risk population:

* NKTR-214/nivolumab: 311 and 256, respectively
* Sunitinib or cabozantinib: 312 and 258, respectively

ORR per mRECIST 1.1 by BICR, ITT All-risk population

ORR per mRECIST 1.1 by BICR, ITT I/P-risk population

A total of 623 patients randomized in the ITT All-risk population, including 514 patients for the ITT I/P-risk population:

* NKTR-214/nivolumab: 311 (ITT All-risk population) and 256 (ITT I/P-risk population), respectively
* Sunitinib or Cabozantinib (TKI): 312 (ITT All-risk population) and 258 (ITT I/P-risk population), respectively

Objective Response Rate (ORR) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC

OS, ITT All-risk population

OS, ITT I/P-risk population

Overall Survival (OS) in IMDC All-Risk and Intermediate- or Poor-risk Patients With Previously Untreated Advanced RCC

PFS per mRECIST 1.1. by BICR, ITT All-risk population

PFS per mRECIST 1.1. by BICR, ITT I/P-risk population

Progression Free Survival (PFS) Per mRECIST 1.1 by BICR in IMDC All-risk Patients and Intermediate- or Poor (I/P)-Risk Patients With Previously Untreated Advanced RCC

Overall Study

Symptoms and General Pathology

Neoplasm Metastasis

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Neoplastic Processes

Urinary Bladder Diseases

Transitional Cell Carcinoma

Cisplatin

Immunomodulating Agents

Participants will receive bempegaldesleukin (NKTR-214) in combination with nivolumab.

Bempegaldesleukin

The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.

A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer

A Phase 2, Single-Arm Study of Bempegaldesleukin (NKTR-214) in Combination With Nivolumab in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients

To evaluate the anti-tumor activity of NKTR-214 in combination with nivolumab by assessing the ORR by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per blinded independent central review (BICR) in patients whose tumors have low programmed cell death ligand 1 (PD-L1) expression. ORR was defined as the percentage of patients with confirmed objective response of Complete Response (CR) or Partial Response (PR) on or before the first progressive disease and any subsequent anticancer therapy.

CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

To evaluate the anti-tumor activity of NKTR-214 in combination with nivolumab by assessing the ORR by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per blinded independent central review (BICR) in all treated patients. ORR was defined as the percentage of patients with confirmed objective response of Complete Response (CR) or Partial Response (PR) on or before the first progressive disease and any subsequent anticancer therapy.

CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

To evaluate the effect of NKTR 214 in combination with nivolumab by assessing DOR by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per blinded independent central review (BICR) in all treated patients and patients whose tumors have low PD-L1 expression.

DOR is defined for patients who have a confirmed Complete Response (CR) or Partial Response (PR) as the date from first documented CR or PR per RECIST 1.1 to the date of documentation of disease progression as assessed by BICR or death due to any cause, whichever is earlier. Patients who do not have disease progression or die will be censored on the date of their last evaluable tumor assessment.

To evaluate the anti-tumor activity of NKTR-214 in combination with nivolumab by assessing the ORR by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by Investigator Assessment in All Treated Patients and Patients Whose Tumors Have Low Programmed Cell Death Ligand (PD-L1) Expression.

ORR was defined as the percentage of patients with confirmed objective response of Complete Response (CR) or Partial Response (PR) on or before the first progressive disease and any subsequent anticancer therapy.

To evaluate the effect of NKTR 214 in combination with nivolumab by assessing DOR by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by Investigator Assessment in all treated patients and patients whose tumors have low PD-L1 expression.

DOR is defined for patients who have a confirmed Complete Response (CR) or Partial Response (PR) as the date from first documented CR or PR per RECIST 1.1 to the date of documentation of disease progression as assessed by BICR or death due to any cause, whichever is earlier. Patients who do not have disease progression or die will be censored on the date of their last evaluable tumor assessment.

Participants will receive bempegaldesleukin (NKTR-214) in combination with nivolumab.

Bempegaldesleukin: Specified dose on specified days

Nivolumab: Specified dose on specified days

Combination of Bempegaldesleukin (NKTR-214) + Nivolumab

Participants received bempegaldesleukin (NKTR-214) at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.

Age < 65

Age 65-84

Age 85 and Over

Age, Customized

Race (NIH/OMB)

United Kingdom

Portugal

Spain

Greece

Canada

Netherlands

Turkey

Belgium

Finland

Italy

Israel

France

Germany

ECOG PS 0

ECOG PS 1

ECOG PS 2

Measure Description: Eastern Cooperative Oncology Group (ECOG) performance status:

ECOG Performance Status of 0 = Able to carry out all normal activities without restriction ECOG Performance Status of 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature

ECOG Performance Status

The analysis population consisted of 188 patients.

ORR per RECIST 1.1 by BICR in PD-L1 Low Patients

PD-L1 Low

The primary endpoint of ORR per RECIST 1.1 by BICR was evaluated in the Treated PD-L1 Low Population (123 patients).

The Treated Population included 188 patients who were enrolled and received at least one full (or partial dose) of NKTR-214 or nivolumab.

PD-L1 Low: Patients in the Treated Population whose tumors had low PD-L1 expression (defined as Combined Positive Score \[CPS\] \< 10). From the 188 patients, 123 had tumors with low PD-L1 expression.

Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Per Blinded Independent Central Review (BICR) in Patients Whose Tumors Have Low Programmed Cell Death Ligand (PD-L1) Expression

Participants received bempegaldesleukin (NKTR-214) at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.

The Treated Population included 188 patients; from these, 123 had tumors with low PD-L1 expression, 59 had tumors with high PD-L1 expression, and 6 had unknown PD-L1 expression.

The secondary endpoint of ORR per RECIST 1.1 by BICR was evaluated in the Treated Population (188 patients).

Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Per Blinded Independent Central Review (BICR) in All Treated Patients

Combination of Bempegaldesleukin (NKTR-214) + Nivolumab (All Treated Population)

Arm Group Description: Participants received bempegaldesleukin (NKTR-214) at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.

Combination of Bempegaldesleukin (NKTR-214) + Nivolumab (PD-L1 Low Population)

All Treated Population who had a confirmed Complete Response (CR) or Partial Response (PR) per RECIST 1.1.

Treated PD-L1 Low: Patients in the Treated Population whose tumors had low PD-L1 expression (defined as Combined Positive Score \[CPS\] \< 10).

Duration of Response (DOR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Per Blinded Independent Central Review (BICR) in in All Treated Patients and Patients Whose Tumors Have Low Programmed Cell Death Ligand (PD-L1) Expression

Participants received bempegaldesleukin (NKTR-214) at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.

The Treated Population included 188 patients.

Arm Group Description: Participants received bempegaldesleukin (NKTR-214) at 0.006 mg/kg administered every 3 weeks (q3w) in combination with 360 mg nivolumab q3w.

The PD-L1 Low Population included 123 patients.

The All Treated Population included 188 patients who were enrolled and received at least one full (or partial dose) of NKTR-214 or nivolumab.

Treated PD-L1 Low: Patients in the Treated Population whose tumors had low PD-L1 expression (defined as Combined Positive Score \[CPS\] \< 10). From the 188 patients, 123 had tumors with low PD-L1 expression.

Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator in All Treated Patients and Patients Whose Tumors Have Low Programmed Cell Death Ligand (PD-L1) Expression

Duration of Response (DOR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator in All Treated Patients and Patients Whose Tumors Have Low Programmed Cell Death Ligand (PD-L1) Expression

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)	NCT03729245	Renal Cell Carc... Metastatic Rena...	bempegaldesleuk... sunitinib nivolumab cabozantinib	18 Years -	Nektar Therapeutics
A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer	NCT03785925	Urinary Bladder... Neoplasm Metast...	Bempegaldesleuk... Nivolumab	18 Years -	Nektar Therapeutics

Spots Global Cancer Trial Database for cd122

Every month we try and update this database with for cd122 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cd122

Every month we try and update this database with for cd122 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cd122 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.