All Drugs and Chemicals

Antineoplastic Agents

Immunomodulating Agents

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

BMS-986258

rHuPH20

Bristol-Myers Squibb

The purpose of this study is to determine whether BMS-986258 both monotherapy and in combination with Nivolumab is safe and tolerable in the treatment of advanced malignant tumors.

An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread

A Phase 1/2 First-in-Human Study of BMS-986258 Alone and in Combination With Nivolumab in Advanced Malignant Tumors

Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

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

Nivolumab and rHuPH20

BMS Study Connect Contact Center www.BMSStudyConnect.com

First line of the email MUST contain NCT # and Site #.

Site 0045

Ignacio Magri, Site 0030

Site 0029

Site 0046

Simon Fu, Site 0053

Alvin Tan, Site 0041

Navin Wewala, Site 0078

The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread. The purpose of this study's substudy is to evaluate drug level biocomparability of subcutaneous nivolumab manufactured using two different manufacturing processes.

A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread

A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Have Received Prior Systemic Therapy

Relatlimab

relatlimab

nivolumab

This study will characterize the movement of drugs within the body, evaluate safety and determine to which extent the body can process relatlimab in combination with nivolumab in subjects with certain advanced tumors

A Phase 1, Bioavailability Study of Relatlimab in Combination With Nivolumab

A Phase 1, Multi-Tumor, Bioavailability Study of Relatlimab in Combination With Nivolumab

BMS-986179 + nivolumab, dose as specified

BMS-986179

The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.

An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab

A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination With Nivolumab (BMS-936558) in Subjects With Advanced Solid Tumors

Number of participants with drug related adverse events (AE), drug related serious adverse events (SAE), drug related AEs Leading to discontinuation and drug related deaths

Best overall response (BOR) is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. CR or PR determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met.

ORR is defined as the percentage of all treated participants whose BOR is either a CR or PR.

PFSR at 24 weeks is defined as the percentage of treated participants remaining progression free and surviving at 24 weeks.

DOR (computed for all treated subjects with a BOR of CR or PR) is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first.

Cmax is defined as maximum plasma concentration of the drug

Tmax is defined is the time to maximum plasma concentration

Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration

Area under the plasma concentration time-curve. AUC over the dosing interval.

Ctau is defined as the concentration of study drug at the end of the dosing interval

Mean change from baseline in CD73 assays at the end of Part 1A treatment period

Assays Measured:

EHC CD73 H-score IHC CD73 Cytoplasm H-Score IHC CDS73 Membrane H-Score

The H-score is given by the ratio of the weighted sum of the number of positive cells to the total number of detected cells. The H-score captures both the intensity and the proportion of the biomarker of interest from the IHC image and comprises values between 0 and 300. The lower the number equals a better prognosis.

A participant with at least one ADA-positive sample relative to baseline at any time after initiation of treatment with BMS-986179 and nivolumab.

P1A 150mg

P1A 300mg

P1A 600mg

P1A 1200mg

P1A 1600mg

P1A all treated participants in monotherapy

P1A All Mono

P1A Combo Therapy 150mg

P1A Combo Therapy 300mg

P1A Combo Therapy 600mg

P1A Combo Therapy 1200mg

P1A Combo Therapy 1600mg

P1A all treated participants in combo therapy

P1A All Combo

P1B Combo Therapy 150mg

P1B Combo Therapy BMS-986179 1200mg + Nivo360mg

P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg

P1B BMS-986179 1600mg

All treated participants in P1B combo therapy period

P1B All Combo

P2 Combo Pancreatic

P2 Combo NSCLC

P2 Combo Melanoma

P2 Combo SCCHN

P2 RCC Combo

P2 RCC Mono

P2 RCC Crossover

P2 Combo Prostate

P2 Monotherapy Unassigned

P2 Combo Unassigned

All Treated participants in the P2 treatment period

P2 All Combo Therapy

All treated participants in P1A, P1B and P2 combo therapy periods

ALL Combo (P1A+P1B+P2)

BMS-986179 150mg monotherapy leading into BMS-986179 150mg + Nivo 240 combo therapy

BMS-986179 300mg monotherapy leading into BMS-986179 300mg + Nivo 240mg combo therapy

BMS-986179 600mg monotherapy leading into BMS-986179 600mg + Nivo 240mg combo therapy

BMS-986179 1200mg monotherapy leading into BMS-986179 1200mg + Nivo 240mg combo therapy

BMS-986179 1600mg monotherapy leading into BMS-986179 1600mg + Nivo 240mg combo therapy

P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg

P1B BMS986-179 1600mg

P2 Combo Therapy NSCLC

BMS-986179 600mg Q2W + Nivo 480mg Q4W combo therapy

P2 Combo Unassiged

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Bristol-Myers Squibb Study Director

Adverse Events

Serious Adverse Events

AEs Leading to Discontinuation

Deaths

P2 Combo RCC Crossover

Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.

Complete Response

Partial Response

Number of Participants With a Best Overall Response (BOR) at Week 24

Percentage of Participants With an Objective Response Rate (ORR) at Week 24

Progression Free Survival Rate (PFSR) at Week 24

Median Duration of Response (DOR)

Cycle 0 Day 1

Cycle 1 Day 1

Cycle 1 Day 22

Cycle 2 Day 1

Cycle 4 Day 15

All Treated Participants with evaluable cmax measurements at specified time points

Cmax

All Treated Participants with evaluable tmax measurements at specified time points

Tmax

All Treated Participants with evaluable AUC (0-T) measurements at specified time points

AUC (0-T)

All Treated Participants with evaluable AUC (Tau) measurements at specified time points

AUC (Tau)

All Treated Participants with evaluable Ctau measurements at specified time points

Ctau

EHC CD73 H-Score

IHC CD73 Cytoplasm H-Score

IHC CD73 Membrane H-Score

All Treated Participants with evaluable CD73 assay measurements for each assay

Mean Change From Baseline in CD73 Assays

BMS-986179 ADA+

Nivolumab ADA+

BMS-986179 150mg monotherapy leading into BMS-986179 150mg + Nivo 240mg Combo Therapy

BMS-986179 300mg monotherapy leading into BMS-986179 300mg + Nivo 240mg Combo Therapy

BMS-986179 600mg monotherapy leading into BMS-986179 600mg + Nivo 240mg Combo Therapy

BMS-986179 1200mg monotherapy leading into BMS-986179 1200mg + Nivo 240mg Combo Therapy

BMS-986179 1600mg monotherapy leading into BMS-986179 1600mg + Nivo 240mg Combo Therapy

All Treated Participants with evaluable ADA measurements

Number of Participants With a Positive Anti-drug Antibody (ADA) Test.

P2 RCC Monotherapy

P2 RCC Combo Therapy

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Atezolizumab

Atezolizumab+recombinant human hyaluronidase (rHuPH20), followed by Atezolizumab

Atezolizumab+rHuPH20, followed by Atezolizumab

Atezolizumab will be administered as per the schedule specified in arm or cohort.

rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.

Clinical Trials

This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV) in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have not been exposed to cancer immunotherapy (CIT) and for whom prior platinum-based therapy has failed. The study is comprised of two parts, as follows: A dose-finding part (Part 1, Phase Ib) will aim to identify the dose of atezolizumab SC to be tested in Part 2. A dose-confirmation part (Part 2, Phase III, randomized) will aim to confirm that the dose moved forward from Part 1 yields drug exposure that is comparable to that of atezolizumab IV.

Intervention study model can be sequential or in parallel.

A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Randomized, Multicenter, Phase Ib/III Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous Compared With Atezolizumab Intravenous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Cycle length =21 days for cohorts 1 and 3 and 14 days for cohort 2. Day=D; Cycle=C.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 5.0 (NCI-CTCAE, v5.0).

1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo.

1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo

ORR is defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. CR is the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to \< 10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the Baseline sum diameters in the absence of CR.

PFS is defined as the time from study start to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or or death from any cause (whichever occurs first).

OS defined as the time from study entry to death from any cause.

DOR is defined as the time from first occurrence of a documented objective response to disease progression as determined by the investigator according to RECIST v1.1. or death from any cause, whichever occurs first. Objective response is defined as the percentage of participants having a CR or PR as determined by investigator assessment of radiographic disease per RECIST v1.1. CR is the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the SOD of target lesions, taking as reference the Baseline sum diameters in the absence of CR.

EORTC IL57 questionnaire has10 items and covers 3 scales: physical functioning (PF), role functioning (RF) \& global health status/quality of life (GHS/QoL) \& 1 item from EORTC Item Library. PF scale has 5 items evaluating the extent to which participants have trouble doing strenuous activities; taking long walks \& short walks; need to stay in bed or a chair; need help with eating, dressing, bathing/using toilet. RF scale has 2 items evaluating extent to which participants are limited in doing work \& pursuing leisure activities in previous week. GHS/QoL scale has 2 items evaluating participants' overall health \& QoL in previous week. Questions are answered on a 4-point Likert scale (where 1="Not at all" to 4="Very much") for physical and role functioning \& a 7-point scale (where 1="Very poor" to 7="Excellent") for GHS/QoL. For each scale, mean of the items are linearly transformed to obtain scores from 0-100, where 100 =best possible score. Higher score = better outcome.

Modified SWT scale of the CTSQ consist of seven items that measures seven domains related to satisfaction with cancer therapy. These include worthwhile, difficulty, benefits, feelings about side effects, form of therapy, overall satisfaction, and if participants would choose the therapy taking everything into consideration. Each domain is rated on a 5-point scale, with 1 representing the worst response and 5 representing the best response, except in the case of one reverse-scored item. mean of the items are linearly transformed to obtain scores from 0-100, where 100 =best possible score Higher scores are associated with higher satisfaction.

The overall patient-reported AE burden was assessed using the a single item from the EORTC IL57 questionnaire i.e To what extent have you been troubled with side-effects from your treatment?. The questions is answered on a 4-point Likert scale where 1="Not at all" to 4="Very much". Higher scores indicates greater AE burden.

The HCP Subcutaneous Versus IV Perspective Questionnaire consists of five items evaluating the number of atezolizumab SC and IV administrations done, convenience, potential time savings, and overall satisfaction with atezolizumab SC and atezolizumab IV, as well as reasons for HCP-reported satisfaction or dissatisfaction.

The HCP Subcutaneous Perspective Questionnaire consists of five items evaluating the convenience, ease of administration and overall satisfaction with atezolizumab SC, as well as reasons for HCP-reported satisfaction or dissatisfaction.

Hoffmann-La Roche

Safety-evaluable population included all participants who received at least one dose of atezolizumab (atezolizumab SC or atezolizumab IV)

Participants received 1800 mg of atezolizumab co-mixed with rHuPH20, as SC injection, on Day 1 of Cycle 1 (1 cycle=21 days), followed by 1200 mg of atezolizumab as IV infusion, Q3W, on Day 1 of subsequent cycles until disease progression, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.

Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg

Participants received 1200 mg of atezolizumab co-mixed with rHuPH20, as SC injection, Q2W on Day 1, for first 3 cycles (Cycle 1-3=14 days), followed by 1200 mg of atezolizumab as IV infusion, Q3W, on Day 1 of subsequent cycles (1 cycle=21 days) until disease progression, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread	NCT03446040	Advanced Cancer	BMS-986258 Nivolumab rHuPH20	18 Years -	Bristol-Myers Squibb
A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread	NCT04810078	Clear Cell Rena...	Nivolumab and r... Nivolumab	18 Years -	Bristol-Myers Squibb
An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread	NCT03446040	Advanced Cancer	BMS-986258 Nivolumab rHuPH20	18 Years -	Bristol-Myers Squibb
A Phase 1, Bioavailability Study of Relatlimab in Combination With Nivolumab	NCT04112498	Cancer	relatlimab nivolumab rHuPH20	18 Years -	Bristol-Myers Squibb
An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab	NCT02754141	Malignant Solid...	BMS-986179 Nivolumab rHuPH20	18 Years -	Bristol-Myers Squibb
A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer	NCT03735121	Non-Small Cell ...	Atezolizumab rHuPH20	18 Years -	Hoffmann-La Roche
An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread	NCT03446040	Advanced Cancer	BMS-986258 Nivolumab rHuPH20	18 Years -	Bristol-Myers Squibb
A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma	NCT05625399	Melanoma	Nivolumab + Rel... rHuPH20	12 Years -	Bristol-Myers Squibb
An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab	NCT02754141	Malignant Solid...	BMS-986179 Nivolumab rHuPH20	18 Years -	Bristol-Myers Squibb

Spots Global Cancer Trial Database for rhuph20

Every month we try and update this database with for rhuph20 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 rhuph20

Every month we try and update this database with for rhuph20 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 rhuph20 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.