Lung Cancer Clinical Trial

A Safety and Efficacy Study of CC-90011 in Combination With Nivolumab in Subjects With Advanced Cancers

Summary

This is a Phase 2, multicenter, open-label, multi-cohort study to assess safety and efficacy of CC-90011 in combination with nivolumab in subjects with small cell lung cancer or squamous non-small cell lung cancer who have progressed after 1 or 2 lines of therapies.

The primary objectives of the study are to evaluate the overall response rate of subjects treated with CC-90011 in combination with nivolumab in three cohorts:

Cohort A: SCLC in ICI naïve subjects
Cohort B: SCLC in ICI progressor subjects
Cohort C: sqNSCLC in ICI progressor subjects Overall response rate is defined as the proportion of subjects in the treated population who had complete response (CR) or partial response (PR) as assessed by Investigator review per RECIST v1.1.

In Cohort A, expected ORR for nivolumab monotherapy is 14% while target ORR is 30%. To achieve at least 80% power with one-sided type 1 error 0.1, 39 subjects will be enrolled according to a 2-stage group sequential design based on a binomial test. In stage 1, 12 subjects will be enrolled and treated with CC-90011 in combination with nivolumab. If there are 2 or more subjects responding, Cohort A will continue to enroll an additional 27 subjects. If 1 or less subjects respond in stage 1, Cohort A will stop for futility.

In Cohort B and C, expected ORR for nivolumab monotherapy is 5% while target ORR is 15%. To achieve at least 80% power with one-sided type 1 error 0.1, 48 subjects will be enrolled according to a 2-stage group sequential design based on a binomial test. In stage 1, 14 subjects will be enrolled and treated with CC-90011 in combination with nivolumab. If there are 1 or more subjects responding, Cohort B and C will continue to enroll an additional 34 subjects each. If 0 subjects respond in stage 1, Cohort B and C will stop for futility.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
Subject with histological or cytological confirmation of extensive stage Small Cell Lung Cancer (ES SCLC) or Stage IIIb or IV squamous Non-Small Cell Lung Cancer (sqNSCLC)

Subject has received 1 or 2 prior lines of therapies, defined as:

Cohort A (SCLC, Immune Checkpoint Inhibitor naïve):

At least 1 prior treatment including a platinum-based chemotherapy doublet
A minimum of 3 cycles of platinum-based chemotherapy in first line treatment, unless stopped at 2 cycles due to treatment-related toxicity

Cohort B (SCLC, ICI progressors):

At least 1 prior first or second line treatment includes an ICI
If treatment includes an ICI as maintenance therapy, at least 1 cycle of ICI in maintenance should have been completed
At least 1 prior treatment including a platinum-based chemotherapy doublet
A minimum of 3 cycles of platinum-based chemotherapy, with or without ICI, in first line treatment, unless stopped at 2 cycles due to treatment-related toxicity
Subject must have progressed during ICI therapy, defined as unequivocal progression on or within 3 months of the last dose of ICI therapy (if no subsequent therapy)

Cohort C (sqNSCLC, ICI progressors):

At least 1 prior first or second line treatment includes an ICI
If treatment includes an ICI as maintenance therapy, at least 1 cycle of ICI in maintenance should have been completed
At least 1 prior treatment including a platinum-based chemotherapy doublet
A minimum of 3 cycles of platinum-based chemotherapy, with or without an ICI, in first line treatment, unless stopped at 2 cycles due to treatment-related toxicity
Subject must have progressed during ICI therapy, defined as unequivocal progression on or within 3 months of the last dose of ICI therapy (if no subsequent therapy)
Subject has progressed at the last line of therapy.
Subject has a measurable disease defined by RECIST v1.1.
Subject agrees to provide a tumor biopsy from primary or metastatic site prior to first dose and at a pre-specified timepoint during treatment. Core biopsy is required however, in the event a core biopsy may not otherwise be feasible in the opinion of the treating physician, an endobronchial ultrasound-guided fine needle aspirate [EBUS-FNA]) biopsy, using the largest gauge needle, may be performed instead.
Subject has ECOG Performance Status of 0 to 1.

Subject must have the following laboratory values:

Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
Hemoglobin (Hgb) ≥ 9 g/dL (one-time blood transfusion is allowed)
Platelet (Plt) Count ≥ 150 x 109/L
White blood cells (WBC) ≥ 2 x 109L
Serum AST/serum glutamic oxaloacetic transaminase (SGOT) or ALT/serum glutamic pyruvic transaminase (SGPT) ≤ 3 x upper limit of normal (ULN) or ≤ 5 x ULN if presence of liver metastases
Total serum bilirubin ≤ 1.5 x ULN (≤ 3 x ULN, if Gilbert's syndrome or if indirect bilirubin concentrations are suggestive of extrahepatic source of the elevation)
Creatinine clearance (CrCl) ≥ 60 mL/minute based on Cockcroft-Gault or modification of diet in renal disease (MDRD) or ≥ 60 mL/min/1.73 m2

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

Subject has not recovered to Grade 2 or lower clinically significant toxicities related to the prior therapy (alopecia excluded).
Subject has received prior LSD1 therapies.
Subject has a history of severe hypersensitivity reactions to other monoclonal antibodies

Subject with symptomatic and untreated or unstable central nervous system (CNS) metastases.

Subject has recently been treated with whole brain radiation or stereotactic radiosurgery for CNS metastases must have completed therapy at least 2 weeks prior to Cycle 1 Day 1 and has a follow-up brain computed tomography (CT) or magnetic resonance imaging (MRI) demonstrating either stable or improving metastases 2 or more weeks after completion of radiotherapy.
Subject must be asymptomatic and off steroids or on stable dose of steroids for at least 2 weeks (≤ 10 mg daily prednisone or equivalent) prior to first dose.
Subject has persistent diarrhea due to a malabsorptive syndrome (such as celiac sprue or inflammatory bowel disease) ≥ NCI CTCAE Grade 2, despite medical management), or any other significant gastrointestinal (GI) disorder that could affect the absorption of the study treatments.
Subject with symptomatic or uncontrolled ulcers (gastric or duodenal), particularly those with a history of and/or risk of perforation and GI tract hemorrhages.
Subject with any hemorrhage/bleeding event > NCI CTCAE Grade 2 or haemoptysis > 1 teaspoon within 4 weeks prior to the first dose.

Subject has any of the following cardiovascular criteria:

Evidence of acute or ongoing cardiac ischemia
Current symptomatic pulmonary embolism
Unstable angina pectoris or myocardial infarction ≤ 6 months prior to enrollment
Heart failure of New York Heart Association Classification III or IV ≤ 6 months prior to enrollment
Persistent or clinically meaningful ventricular arrhythmias prior to enrollment
Cerebral vascular accident or transient ischemic attack ≤ 6 months prior to enrollment
QT corrected based on Fridericia's equation (QTcF) ≥ 450 milliseconds (msec) on Screening ECG, a baseline prolongation of QTcF interval ≥ 450 msec (NCI CTCAE Grade ≥ 2)
A history of additional risk factors for Torsades de pointes (TdP) (eg, heart failure, hypokalemia, family history of Long QT Syndrome)
Uncontrolled hypertension (blood pressure ≥ 160/95 mm Hg)
Subject has known human immunodeficiency virus (HIV) infection.

Subject has known chronic active hepatitis B or C virus (HBV, HCV) infection.

Subject who is seropositive due to HBV vaccination is eligible.
Subject who has no active viral infection and is under adequate prophylaxis against HBV reactivation is eligible.
Subject has any other malignancy within 2 years prior to enrollment, with the exception of adequately treated in-situ bladder cancer, in-situ carcinoma of the cervix, uteri, nonmelanomatous skin cancer, ductal in situ breast carcinoma, thyroid cancer, or early stage prostate cancer (all treatment of which should have been completed 6 months prior to enrollment).

Subject has medical conditions requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of enrollment.

A brief (≤ 7 days) course of corticosteroids for prophylaxis (eg, contrast dye allergy) or for treatment of nonautoimmune conditions (eg, delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
Adrenal replacement steroid doses > 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease.
Topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption) are permitted.
Subject has active autoimmune diseases or history of autoimmune diseases that may relapse. Subjects with the following diseases are allowed to be enrolled after further screening: type I diabetes, hypothyroidism managed with hormone replacement therapy only, skin diseases not requiring systemic treatment (such as vitiligo, psoriasis, or alopecia), or diseases not expected to recur in the absence of external triggering factors.
Subject is pregnant or nursing.
Subject has a history of persistent skin rash ≥ NCI CTCAE Grade 2 related to prior ICI therapy.
Subject has organ transplant history, including allogeneic stem cell transplant.
Subject has interstitial lung disease history.
Subject has received a live/attenuated vaccine within 30 days of first dose.

Subject has previous SARS-CoV-2 infection either suspected or confirmed within 4 weeks prior to screening.

Acute symptoms must have resolved and based on Investigator assessment in consultation with the Medical Monitor, there are no sequelae that would place the subject at a higher risk of receiving investigational treatment.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

92

Study ID:

NCT04350463

Recruitment Status:

Active, not recruiting

Sponsor:

Celgene

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There are 41 Locations for this study

See Locations Near You

Augusta University - Georgia Cancer Center
Augusta Georgia, 30912, United States
Investigative Clinical Research of Indiana, LLC
Indianapolis Indiana, 46260, United States
Local Institution - 102
Indianapolis Indiana, 46260, United States
Local Institution - 106
New York New York, 10021, United States
Memorial Sloan-Kettering Cancer Center - David H. Koch Center for Cancer Care
New York New York, 10021, United States
Novant Health Presbyterian Medical Center
Charlotte North Carolina, 28204, United States
Piedmont Hematology Oncology Associates
Winston-Salem North Carolina, 27103, United States
Gabrail Cancer Center Research
Canton Ohio, 44718, United States
Local Institution - 105
Canton Ohio, 44718, United States
Local Institution - 104
Cleveland Ohio, 44106, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
Local Institution - 109
Pittsburgh Pennsylvania, 15232, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15232, United States
Brooke Army Medical Center Francis Street Medical Center
Fort Sam Houston Texas, 78235, United States
Local Institution - 107
Fort Sam Houston Texas, 78235, United States
Local Institution - 110
Houston Texas, 77090, United States
Millennium Oncology
Houston Texas, 77090, United States
Local Institution - 111
Fairfax Virginia, 22031, United States
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States
Hopital Louis Pradel
Lyon Cedex , 69500, France
Local Institution - 156
Lyon Cedex , 69500, France
Hospital Le Timone
Marseille Cedex 5 , 13385, France
Local Institution - 153
Marseille Cedex 5 , 13385, France
Hospital Pontchaillou
Rennes , 35033, France
Local Institution - 154
Rennes , 35033, France
CHU Nantes Hopital Nord Laennec
Saint-Herblain , 44800, France
Local Institution - 151
Saint-Herblain , 44800, France
Gustave Roussy
Villejuif CEDEX , 94805, France
Local Institution - 152
Villejuif CEDEX , 94805, France
Centro di Riferimento Oncologico
Aviano , 33081, Italy
Local Institution - 301
Aviano , 33081, Italy
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)
Meldola , 47014, Italy
Local Institution - 306
Meldola , 47014, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan , 20133, Italy
Local Institution - 303
Milan , 20133, Italy
Local Institution - 305
Roma , 00128, Italy
Policlinico Universitario Campus Biomedico Di Roma
Roma , 00128, Italy
Azienda Ospedaliera Universitaria Integrata di Verona
Verona , 37134, Italy
Local Institution - 304
Verona , 37134, Italy
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz , 90-24, Poland
Local Institution - 451
Lodz , 90-24, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz , 93-33, Poland
Local Institution - 452
Lodz , 93-33, Poland
Local Institution - 454
Poznan , 60-69, Poland
Med Polonia Sp. z o.o. NSZOZ
Poznan , 60-69, Poland
Local Institution - 453
Warsaw , 02-78, Poland
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw , 02-78, Poland
Hospital Universitari Germans Trias i Pujol Can Ruti
Badalona (Barcelona) , 08916, Spain
Local Institution - 351
Badalona (Barcelona) , 08916, Spain
Hospital Quiron Barcelona
Barcelona , 08023, Spain
Local Institution - 355
Barcelona , 08023, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Local Institution - 356
Barcelona , 08035, Spain
Complejo Universitario La Coruna
La Coruna , 15006, Spain
Local Institution - 361
La Coruna , 15006, Spain
Insular-Maternal and Child University Hospital Complex
Las Palmas de Gran Canaria , 35016, Spain
Local Institution - 359
Las Palmas de Gran Canaria , 35016, Spain
Clinica Universidad de Navarra
Madrid , 28027, Spain
Local Institution - 358
Madrid , 28027, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28040, Spain
Local Institution - 353
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Local Institution - 357
Madrid , 28041, Spain
Hospital Puerta de Hierro
Majadahonda, Madrid , 28222, Spain
Local Institution - 360
Majadahonda, Madrid , 28222, Spain
Clinica Universidad de Navarra
Pamplona , 31008, Spain
Local Institution - 352
Pamplona , 31008, Spain
Hospital General de Valencia
Valencia , 46014, Spain
Local Institution - 362
Valencia , 46014, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia , 46026, Spain
Local Institution - 354
Valencia , 46026, Spain
Clatterbridge Centre for Oncology NHS Trust
Bebington, Wirral , CH63 , United Kingdom
Local Institution - 254
London , SW3 6, United Kingdom
The Royal Marsden Hospital
London , SW3 6, United Kingdom
Local Institution - 251
Manchester , M20 4, United Kingdom
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom
Local Institution - 255
Sutton-Surrey , SM2 5, United Kingdom
Royal Marsden Hospital
Sutton-Surrey , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

92

Study ID:

NCT04350463

Recruitment Status:

Active, not recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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