Trials Sponsors Conditions Drugs Pricing

Conditions

Advanced Stage Non-small Cell Lung Cancer

Keywords

NivolumabLungipilimumabNSCLC14-137

Outcome Measures

Primary Outcomes (1)

Best Overall Response Rate (Confirmed Partial + Complete Response) Will be Assessed as Part of This Study. Tumor Response Will be Assessed Using RECIST 1.1)
confirmed partial + complete response will be assessed as part of this study. Tumor response will be assessed using RECIST 1.1. All responses must be confirmed on subsequent scan to be considered a true response. Tumor assessments will be performed after.6 weeks (+/- 1 week) and subsequently every six week (+/- 1 week) thereafter while on study until week 48. After week 48, tumor assessments will be conducted every 12 weeks (+/- week). Additional tumor assessments may be performed at the discretion of the treating physician.
every 6 weeks (+/- 1 week) until week 48

Study Arms (1)

Nivolumab

EXPERIMENTAL

Patients will begin treatment with nivolumab IV 3mg/kg and ipilimumab 1mg/kg. Treatment with nivolumab will continue every 2 weeks (+/- 3 days) thereafter and treatment with ipilimumab will continue every 6 weeks (+/- 3 days) thereafter. Treatment will continue until protocol-defined toxicity, confirmed progression of disease\*, withdrawal of consent, or death.

Drug: nivolumabDrug: pilimumab

Interventions

nivolumabDrug

Nivolumab

pilimumabDrug

Nivolumab

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient must be capable, willing, and able to provide written, informed consent.
≥ 18 years old.

Sponsors & Collaborators

Memorial Sloan Kettering Cancer Center
Otherlead
Bristol-Myers Squibb
Industrycollaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

MeSH Terms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title: Dr. Adam Schoenfeld, MD
Organization: Memorial Sloan Kettering Cancer Center

Study Officials

Adam Schoenfeld, MD
Memorial Sloan Kettering Cancer Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

29 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 20, 2015

First Posted

January 30, 2015

Study Start

January 20, 2015

Actual (reported)

Primary Completion

You may not qualify if:

Patients who are pregnant or lactating.
Presence of activating EGFR mutations or ALK re-arrangement,unless previously treated with standard TKI therapy. All patients with adenocarcinoma histology must be tested for EGFR and ALK status.
History of allergy to study drug components or history of severe hypersensitivity reaction of any monoclonal antibody.
Prior treatment with immune checkpoint inhibitor, including (but not limited to) those targeting PD-1, PD-L1, PD-L2, CTLA-4, CD137, GITR, TIM3, LAG3, or OX40
Any systemic anti-cancer therapy within 3 weeks prior to C1D1 of study therapy
Exception is made for patients with EGFR or ALK re-arrangements who must have stopped TKI therapy at least 7 days prior to C1D1
Patients who have not previously been treated with platinum-based based doublet chemotherapy and who, in the judgment of the investigator, have rapidly progressive disease such that serious complications may arise from disease progression within the next 12 weeks will be excluded.
Non-CNS radiotherapy within 1 week prior to C1D1 of study therapy
Active infection requiring therapy
Prior systemic immunosuppressive therapy (\> 10 mg/day prednisone equivalents) within 1 week prior to C1D1 of study therapy. Inhaled, ocular, intra-articular, intranasal, and topical corticosteroids are permitted in absence of active autoimmune disease.
Adrenal replacement doses are permitted in the absence of active autoimmune disease.
Patients with known or suspected history of autoimmune disease. Subjects with type I diabetes melitis, hypothyroidism only requiring hormone replacement, resolved childhood asthma/atopy, patients with asthma requiring intermittent bronchodilator therapy, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
Other active malignancy requiring concurrent intervention.
Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless definitive therapy has been completed at least 1 year prior to study entry and the patient is now without evidence of disease from that malignance and no additional therapy is required or anticipated to be required during the study period.
Known untreated brain or leptomeningeal metastasis.
+4 more criteria

Evaluate the Mediators of Sensitivity and Resistance to Nivolumab Plus Ipilimumab in Patients With Advanced NSCLCs

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Nivolumab

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Nivolumab

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations