NCT03444766

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

March 6, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2019

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 4, 2020

Completed
Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

1.4 years

First QC Date

February 20, 2018

Results QC Date

October 16, 2020

Last Update Submit

December 3, 2020

Conditions

Non-Small Cell Lung Cancer (NSCLC)Non-Small-Cell Lung CarcinomaNonsmall Cell Lung CancerKidney CancerKidney NeoplasmsRenal CancerRenal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment-related Adverse Events

    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.

    26 Weeks

Secondary Outcomes (3)

  • Number of Participants With Treatment-related Select Adverse Events

    26 Weeks

  • Number of Participants With Treatment-related Serious Adverse Events

    26 Weeks

  • Number of Participants With Adverse Events Leading to Discontinuation

    26 Weeks

Study Arms (1)

Monotherapy

EXPERIMENTAL

administering nivolumab only

Drug: Nivolumab

Interventions

NivolumabDRUG

specified dose on specified days

Also known as: Opdivo
Monotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Local Institution

Bangalore, 560027, India

Location

Local Institution

Bangalore, 560072, India

Location

Local Institution

Bengaluru, 560054, India

Location

Local Institution

Hyderabad, 500034, India

Location

Local Institution

Jaipur, 302004, India

Location

Local Institution

Kolkata, 700156, India

Location

Local Institution

Mumbai, 400012, India

Location

Local Institution

New Delhi, 110029, India

Location

Local Institution

Vellore, 632004, India

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungKidney Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Bristol-Myers Squibb Study Director
Organization
Bristol-Myers Squibb
Clinical.Trials@bms.com
Please Email

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2018

First Posted

February 23, 2018

Study Start

March 6, 2018

Primary Completion

July 17, 2019

Study Completion

July 17, 2019

Last Updated

December 4, 2020

Results First Posted

December 4, 2020

Record last verified: 2020-12

Locations

IN(9)