Clinical trial NCT04151563: A Clinical Study Evaluating Nivolumab-containing Treatments in Patients With Advanced Non-small Cell Lung Cancer After Failing Previous PD-1/(L)1 Therapy and Chemotherapy
Official title: A Phase 1/2, Randomized Study Evaluating Multiple Nivolumab Combination Therapies in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy and Anti-PD-1 (L)1 Immunotherapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Non-small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Clovis Oncology, Inc.
name: Exelixis
name: Eli Lilly and Company
First posted: 2019-11-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is for participants with Non-small Cell Lung Cancer that has spread or has reoccurred after failure of Chemotherapy and Immunotherapy


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

Inclusion Criteria

* Histologically or cytologically-documented Stage IV A/B non-small cell lung Cancer, stage IIIB/C disease failed concurrent chemoRT.
* ECOG Performance Status of ≤ 1.
* Radiologically-documented disease progression on one anti-PD-1/anti-PD-L1 therapy and one platinum-based doublet regimen given either concurrently or sequentially within 90 days after the last dose of anti-PD-(L)1.
* All participants must have tumor tissue submitted prior to randomization, either a recent archival sample obtained on/after the date of disease progression of the last prior anticancer therapy and within 3 months prior to enrollment, or a fresh biopsy obtained during the screening period.
* Prior toxicities must have resolved to grade ≤1.
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test and must not be breastfeeding.
* Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception. In addition, male participants must be willing to refrain from sperm donation during this time and must agree to follow instructions for method(s) of contraception. Azoospermic males are exempt from contraceptive requirements as well as WOCBP who are continuously not heterosexually active, however, a pregnancy test will still be required.

Exclusion Criteria

* Prior treatment with Docetaxel.
* Untreated CNS metastases, carcinomatous meningitis or leptomeningeal metastases.
* Any tumor invading the Superior Vena Cava other blood vessel, GI Tract or Trachea.
* EGFR mutations, ALK translocations, ROS1 translocations which are sensitive to inhibitor therapy.
* History of cerebrovascular accident and coagulation disorders.
* Participants with interstitial lung disease, history of cerebrovascular accident or history of abdominal fistula, gastrointestinal perforation, bowel obstruction, intra-abdominal abscess or grade 3-4 bleeding event within 6 months prior to randomization.
* Known toxicity on prior checkpoint inhibitor treatment.
* Participants who received more than one line of anti- PD-1/PD-L1 treatment.
* Participants who received previous CTLA-4 inhibitor treatment.
* Participants with known BRAF V600E mutation which are sensitive to available targeted inhibitor therapy are excluded.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Overall Reponse Rate (ORR) using RECIST 1.1 per Blinded Independent Central Review (BICR) assessment
timeFrame: approximately 33 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 5 Years
measure: Duration of Response (DOR) by BICR using RECIST 1.1
timeFrame: approximately 33 months
measure: Progression-Free Survival (PFS) by BICR using RECIST 1.1
timeFrame: Up to 5 Years
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 5 Years
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 5 Years
measure: Incidence of Select AEs
timeFrame: Up to 5 Years
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Local Institution
state: Michigan
city: Ciudad Autónoma De Buenos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution
state: Distrito Federal
city: Buenos Aires
country: Argentina
facility: Local Institution
state: Distrito Federal
city: Caba
country: Argentina
facility: Local Institution
state: Distrito Federal
city: Capital
country: Argentina
facility: Local Institution
state: Distrito Federal
city: Charleroi
country: Belgium
facility: Local Institution
city: Gilly
country: Belgium
facility: Local Institution
city: Leuven
country: Belgium
facility: Local Institution
city: Copenhagen Ø
country: Denmark
facility: Local Institution
city: Athens
country: Greece
facility: Local Institution
city: Neo Faliro
country: Greece
facility: Local Institution
city: Torreon
country: Mexico
facility: Local Institution
state: Coahuila
city: Ciudad de México
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Zapopan
country: Mexico
facility: Local Institution
state: Jalisco
city: Heroica Puebla de Zaragoza
country: Mexico
facility: Local Institution
state: Puebla
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Rotterdam
country: Netherlands
facility: Local Institution
city: Oslo
country: Norway
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
state: Mazowieckie
city: Krakow
country: Poland
facility: Local Institution
city: Craiova
country: Romania
facility: Local Institution
city: Timisoara
country: Romania
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: