Study of Nivolumab for Advanced Cancers in India

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03444766
• Collaborator: (none)
• Enrollment: 100
• Locations: 9
• Arm: 1
• Actual Duration (Months): 16.4
• Patients Per Site: 11.1
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This is a study of nivolumab in participants with advanced Non-Small Cell Lung Cancer or Kidney Cancer in India.

Condition or Disease	Intervention/Treatment	Phase
Non-Small Cell Lung Cancer (NSCLC); Non-Small-Cell Lung Carcinoma; Nonsmall Cell Lung Cancer; Kidney Cancer; Kidney Neoplasms; Renal Cancer; Renal Neoplasms	Drug: Nivolumab	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety Study of Nivolumab for Selected Advanced Malignancies in India
• Actual Study Start Date: Mar 6, 2018
• Actual Primary Completion Date: Jul 17, 2019
• Actual Study Completion Date: Jul 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Monotherapy administering nivolumab only	Drug: Nivolumab; specified dose on specified days; Other Names: Opdivo

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-related Adverse Events [26 Weeks]

   Number of participants with treatment-related Adverse Events based on worst ctc grade Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.

Secondary Outcome Measures

1. Number of Participants With Treatment-related Select Adverse Events [26 Weeks]

   Number of participants with treatment-related Select Adverse Events based on worst ctc grade for the following categories: Pulmonary, Gastrointestinal, Endocrinopathies, Hepatic, Renal, Skin, Neurological and Hypersensitivity/Infusion reactions Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.

2. Number of Participants With Treatment-related Serious Adverse Events [26 Weeks]

   Number of participants with treatment-related Serious Adverse Events based on worst CTC grade Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.

3. Number of Participants With Adverse Events Leading to Discontinuation [26 Weeks]

   Number of participants with Adverse events leading to discontinuation of treatment based on worst CTC grade Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy OR advanced renal cell carcinoma (RCC) after prior therapy

• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

• Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to randomization

Exclusion Criteria:

• Participants with untreated, symptomatic central nervous system (CNS) metastases

• Participants with carcinomatous meningitis

• Participants with active, known or suspected autoimmune disease

• Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications

• Other active malignancy requiring concurrent intervention

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Bangalore		India	560027
2	Local Institution	Bangalore		India	560072
3	Local Institution	Bengaluru		India	560054
4	Local Institution	Hyderabad		India	500034
5	Local Institution	Jaipur		India	302004
6	Local Institution	Kolkata		India	700156
7	Local Institution	Mumbai		India	400012
8	Local Institution	New Delhi		India	110029
9	Local Institution	Vellore		India	632004

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

• Statistical Analysis Plan - May 7, 2019
• Study Protocol - Nov 16, 2017

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03444766
• Other Study ID Numbers: CA209-887
• First Posted: Feb 23, 2018
• Last Update Posted: Dec 4, 2020
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Lung Neoplasms; Neoplasms; Carcinoma, Non-Small-Cell Lung; Kidney Neoplasms; Nivolumab

Study Results

Participant Flow

Pre-assignment Detail	100 participants treated

Arm/Group Title	Nivolumab
Arm/Group Description	3mg/kg IV q 2weeks
Period Title: Overall Study
STARTED	100
COMPLETED	34
NOT COMPLETED	66

Baseline Characteristics

Arm/Group Title	Nivolumab
Arm/Group Description	3mg/kg IV q 2weeks
Overall Participants	100
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	54.7 (10.79)
Sex: Female, Male (Count of Participants)
Female	22 22%
Male	78 78%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	0 0%
Unknown or Not Reported	100 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	100 100%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-related Adverse Events
Description	Number of participants with treatment-related Adverse Events based on worst ctc grade Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
Time Frame	26 Weeks

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Nivolumab
Arm/Group Description	3mg/kg IV q 2weeks
Measure Participants	100
Any Grade	25 25%
Grade 3-4	4 4%
Grade 5	1 1%

2. Secondary Outcome

Title	Number of Participants With Treatment-related Select Adverse Events
Description	Number of participants with treatment-related Select Adverse Events based on worst ctc grade for the following categories: Pulmonary, Gastrointestinal, Endocrinopathies, Hepatic, Renal, Skin, Neurological and Hypersensitivity/Infusion reactions Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
Time Frame	26 Weeks

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Nivolumab
Arm/Group Description	3mg/kg IV q 2weeks
Measure Participants	100
Pulmonary (Grade 3)	1 1%
Pulmonary (Grade 5)	1 1%
Hepatic (Grade 1)	1 1%
Skin (Grade 1)	2 2%
Hypersensitivity/Infusion reaction (Grade 1)	1 1%
Hypersensitivity/Infusion reaction (Grade 2)	2 2%

3. Secondary Outcome

Title	Number of Participants With Treatment-related Serious Adverse Events
Description	Number of participants with treatment-related Serious Adverse Events based on worst CTC grade Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
Time Frame	26 Weeks

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Nivolumab
Arm/Group Description	3mg/kg IV q 2weeks
Measure Participants	100
Any Grade	4 4%
Grade 3 - 4	3 3%
Grade 5	1 1%

4. Secondary Outcome

Title	Number of Participants With Adverse Events Leading to Discontinuation
Description	Number of participants with Adverse events leading to discontinuation of treatment based on worst CTC grade Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
Time Frame	26 Weeks

Outcome Measure Data

Analysis Population Description

All treated participants

Arm/Group Title	Nivolumab
Arm/Group Description	3mg/kg IV q 2weeks
Measure Participants	100
Grade 1	7 7%
Grade 2	5 5%
Grade 3	9 9%
Grade 4	0 0%
Grade 5	1 1%

Adverse Events

Time Frame	26 Weeks
Adverse Event Reporting Description	Includes events reported between first dose and 100 days after last dose of Nivolumab or for a total of 26 weeks from first on-study treatment with Nivolumab whichever is earliest.
Arm/Group Title	Nivolumab
Arm/Group Description	3mg/kg IV q 2weeks
All Cause Mortality
	Nivolumab
	Affected / at Risk (%)	# Events
Total	17/100 (17%)
Serious Adverse Events
	Nivolumab
	Affected / at Risk (%)	# Events
Total	30/100 (30%)
Cardiac disorders
Cardiac arrest	2/100 (2%)
Gastrointestinal disorders
Abdominal pain	1/100 (1%)
Intestinal obstruction	1/100 (1%)
General disorders
Asthenia	3/100 (3%)
Pyrexia	1/100 (1%)
Immune system disorders
Haemophagocytic lymphohistiocytosis	1/100 (1%)
Infections and infestations
Lower respiratory tract infection	1/100 (1%)
Malaria	1/100 (1%)
Respiratory tract infection viral	1/100 (1%)
Investigations
Blood electrolytes abnormal	1/100 (1%)
Metabolism and nutrition disorders
Hyperkalaemia	1/100 (1%)
Hypoglycaemia	1/100 (1%)
Pseudohyperkalaemia	1/100 (1%)
Musculoskeletal and connective tissue disorders
Back pain	1/100 (1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression	7/100 (7%)
Metastases to central nervous system	1/100 (1%)
Nervous system disorders
Headache	2/100 (2%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	1/100 (1%)
Chronic obstructive pulmonary disease	1/100 (1%)
Cough	1/100 (1%)
Dyspnoea	3/100 (3%)
Haemoptysis	1/100 (1%)
Pneumonia aspiration	1/100 (1%)
Pneumonitis	2/100 (2%)
Pneumothorax	1/100 (1%)
Respiratory failure	2/100 (2%)
Other (Not Including Serious) Adverse Events
	Nivolumab
	Affected / at Risk (%)	# Events
Total	74/100 (74%)
Blood and lymphatic system disorders
Anaemia	8/100 (8%)
Endocrine disorders
Hypothyroidism	6/100 (6%)
Gastrointestinal disorders
Abdominal pain	6/100 (6%)
Constipation	10/100 (10%)
Diarrhoea	6/100 (6%)
Nausea	11/100 (11%)
Vomiting	17/100 (17%)
General disorders
Asthenia	6/100 (6%)
Chest pain	11/100 (11%)
Fatigue	16/100 (16%)
Pyrexia	21/100 (21%)
Metabolism and nutrition disorders
Decreased appetite	11/100 (11%)
Hyponatraemia	6/100 (6%)
Musculoskeletal and connective tissue disorders
Arthralgia	7/100 (7%)
Back pain	13/100 (13%)
Nervous system disorders
Headache	11/100 (11%)
Respiratory, thoracic and mediastinal disorders
Cough	24/100 (24%)
Dyspnoea	14/100 (14%)
Dyspnoea exertional	6/100 (6%)
Haemoptysis	10/100 (10%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.