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Trial record 7 of 113 for:    small cell lung ca | Open Studies

Ipilimumab + Nivolumab w/Thoracic Radiotherapy for Extensive-Stage Small Cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by H. Lee Moffitt Cancer Center and Research Institute
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT03043599
First received: February 2, 2017
Last updated: February 14, 2017
Last verified: February 2017
  Purpose

The purpose of the safety run in Phase I portion of this study is to confirm the recommended Phase II dose of ipilimumab and nivolumab among participants treated with combined thoracic radiation therapy (30 Gy in 10 fractions) and nivolumab/ipilimumab following standard treatment with 4-6 cycles of platinum-based chemotherapy.

The purpose of the Phase II portion of this study is to estimate the 6-month Progression Free Survival (PFS) rate among participants treated with ipilimumab and nivolumab with thoracic radiation therapy (30 Gy in 10 fractions) after standard treatment with 4 to 6 cycles of platinum based chemotherapy.


Condition Intervention Phase
Small Cell Lung Cancer
Extensive-stage Small Cell Lung Cancer
Radiation: Thoracic Radiation Therapy
Drug: Ipilimumab
Drug: Nivolumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Consolidative Ipilimumab and Nivolumab With Thoracic Radiotherapy After Platinum Based Chemotherapy for Patients With Extensive-Stage Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Phase I: Confirmation of Recommended Phase II Dose [ Time Frame: 13 weeks ]
    Recommended Phase II dose of ipilimumab and nivolumab among participants treated with combined thoracic radiation therapy (30 Gy in 10 fractions) and nivolumab/ipilimumab following standard treatment with 4-6 cycles of platinum-based chemotherapy. Investigators will initially enroll 6 patients and wait until completion of the 13-week safety observation period following initiation of ipilimumab + nivolumab combination treatment.

  • Phase II: Progression Free Survival (PFS) [ Time Frame: 6 months ]
    PFS is defined as the duration from date of registration to date of first documentation of progression assessed by local investigator or symptomatic deterioration (as defined above) or death due to any cause.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 1 year ]
    OS is defined as the duration from date of registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact.


Estimated Enrollment: 52
Actual Study Start Date: February 13, 2017
Estimated Study Completion Date: April 2021
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination Therapy
Consolidative Ipilimumab and Nivolumab with Thoracic Radiotherapy after Platinum Based Chemotherapy. Radiotherapy, followed by a 14 to 21 day break between radiotherapy and the beginning of study drug treatment.
Radiation: Thoracic Radiation Therapy
All participants will receive radiation therapy (3Gy x 10 fractions) to the chest for 10 days (Monday through Friday for 2 weeks).
Other Name: radiotherapy
Drug: Ipilimumab
Ipilimumab 3 mg/kg (90 minute IV infusion) will be administered every 3 weeks for 4 doses.
Other Name: YERVOY
Drug: Nivolumab
Nivolumab 1 mg/kg (30 minute IV infusion) will be administered every 3 weeks for 4 doses, followed by nivolumab 480 mg every 4 weeks.
Other Name: OPDIVO

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed Written Informed Consent
  • Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.
  • Patients with Small Cell Lung Cancer (SCLC) documented by histology or cytology from brushing, washing, or needle aspiration of a defined lesion, but not from sputum cytology alone
  • Have presented at initial diagnosis with extensive-stage disease
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
  • Have received 4-6 cycles of platinum-based first-line chemotherapy and have an ongoing response of complete response (CR), partial response (PR), or stable disease (SD) after completion of chemotherapy. Acceptable combinations, as recommended per National Comprehensive Cancer Network (NCCN) guidelines, include cisplatin or carboplatin combined with either etoposide or irinotecan; As an exception to the above criterion, participants receiving only 3 cycles of chemotherapy due to toxicity are eligible, if they have an ongoing PR or CR after the 3rd cycle; Participants who have received > 6 cycles of platinum-based first-line chemotherapy are not eligible.
  • Participants must initiate study treatment with thoracic radiation therapy less than or equal to 8 weeks (56 days) from the last dose of platinum-based first line chemotherapy.
  • Whenever possible, a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or 10 unstained slides of tumor sample (archival or recent) for biomarker evaluation should be made available and submitted to the central lab for correlative studies.
  • Men and women at least 18 years of age
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of thoracic radiation therapy
  • Women must not be breastfeeding.
  • WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of study drug (half-life up to 25 days) plus 30 days (duration of ovulatory cycle) for a total of 5 months post-treatment completion.
  • Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug (s) plus 5 half-lives of the study drug (half-life up to 25 days) plus 90 days (duration of sperm turnover) for a total of 7 months post-treatment completion.
  • Additional criteria may apply

Exclusion Criteria:

  • Participants with previous brain metastases are eligible provided that they are treated and asymptomatic not requiring steroids or anticonvulsants, and have stable disease at the screening tumor assessment. A 4 week disease stable interval as confirmed by MRI or CT brain with contrast is required after treatment of brain metastases before initiation of thoracic radiation therapy. In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of 10 mg daily prednisone (or equivalent).
  • Have received prior chest radiation
  • Carcinomatous meningitis
  • Pleural effusion that cannot be controlled with appropriate interventions
  • All toxicities attributed to prior anti-cancer therapy must have been resolved to Grade 1 (NCI CTCAE Version 4) or baseline before administration of study drug(s) other than: Patients with toxicities attributed to prior anti-cancer therapy that either are not expected to resolve and/or result in long-lasting sequelae, such as neuropathy after platinum-based therapy, or are not expected to interfere with treatment on study, such as fatigue,alopecia, or grade 2 hematologic toxicity are eligible.
  • Women who are pregnant or breastfeeding
  • Active, known, or suspected autoimmune disease. Patients with an autoimmune paraneoplastic syndrome requiring concurrent immunosuppressive treatment are excluded. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, 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.
  • A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Corticosteroids with minimal systemic absorption (inhaled or topical steroids) and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
  • Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways)
  • Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
  • Any patient requiring supplemental oxygen therapy
  • Previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period
  • Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results
  • Major surgery or significant traumatic injury that is not recovered at least 14 days before the initiation of thoracic radiation therapy.
  • Positive test for hepatitis B virus (HBV) using HBV surface antigen (HBVsAg) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection
  • Individuals with a positive test for HCV antibody but no detection of HCV RNA indicating no current infection are eligible
  • Known medical history of testing positive for human immunodeficiency virus (HIV) or known medical history of acquired immunodeficiency syndrome (AIDS)
  • Inadequate hematologic function according to study guidelines
  • Inadequate hepatic function according to study guidelines
  • History of allergy or hypersensitivity to any of the study drugs or study drug components
  • Additional criteria may apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03043599

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Yesenia Artigas    813-745-3931    yesenia.artigas@moffitt.org   
Contact: Bradford A. Perez, M.D.    813-745-4380    bradford.perez@moffitt.org   
Principal Investigator: Bradford A. Perez, M.D.         
Sub-Investigator: Scott Antonia, M.D., Ph.D.         
Sub-Investigator: Alberto Chiappori, M.D.         
Sub-Investigator: Benjamin Creelan, M.D.         
Sub-Investigator: Thomas Dilling, M.D.         
Sub-Investigator: Jhanelle Gray, M.D.         
Sub-Investigator: Eric Haura, M.D.         
Sub-Investigator: Trevor Rose, M.D.         
Sub-Investigator: Tawee Tanvetyanon, M.D.         
Sub-Investigator: Charles Williams, M.D.         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Bristol-Myers Squibb
Investigators
Principal Investigator: Bradford A. Perez, M.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT03043599     History of Changes
Other Study ID Numbers: MCC-18914  CA209-840 
Study First Received: February 2, 2017
Last Updated: February 14, 2017

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.: No

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Thoracic
Radiotherapy
Platinum Based Chemotherapy
Immunotherapy
Ipilimumab
Nivolumab
Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Lung Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 23, 2017