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QUILT-3.055: A Study of ALT-803 in Combination With Pembrolizumab or Nivolumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT03228667
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Altor BioScience

Brief Summary:
This is a Phase IIb, single-arm, open-label study of ALT-803 in combination with pembrolizumab or nivolumab in patients with advanced or metastatic non-small cell lung cancer who have progressed following an initial response to treatment with PD-1 checkpoint inhibitor therapy. All patients will receive four cycles of treatment. Each cycle is six weeks in duration. All patients will receive ALT-803. Patients will also receive either pembrolizumab or nivolumab. Radiologic evaluation will occur at the end of each treatment cycle. Following four cycles of combination treatment, patients will no longer receive ALT-803 but will be eligible to continue their respective pembrolizumab or nivolumab therapy through 24 months, at the discretion of the treating physician. Patients will be followed for disease progression, post-therapies, and survival through 24 months.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: ALT-803 + Pembrolizumab Drug: ALT-803 + Nivolumab Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: QUILT-3.055: A Phase IIb, Single-Arm, Open-Label Study of ALT-803 in Combination With Pembrolizumab or Nivolumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Disease Progression Following an Initial Response to Treatment With PD-1 Checkpoint Inhibitor Therapy
Actual Study Start Date : June 6, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Group A
Patients who are currently receiving PD-1 checkpoint inhibitor therapy and have disease progression after experiencing an initial response (defined as either a complete response (CR) or partial response (PR)) to PD-1 checkpoint inhibitor therapy.
Drug: ALT-803 + Pembrolizumab

Patients will receive 200 mg pembrolizumab as an intravenous infusion over 30 minutes every three weeks (Week 1 and Week 4 of each treatment cycle).

Patients will receive 15 µg/kg ALT-803 administered by subcutaneous injection every three weeks (Week 1 and 4 of each treatment cycle).


Drug: ALT-803 + Nivolumab

Patients will receive 240 mg nivolumab as an intravenous infusion over 30-60 minutes every two weeks (Week 1, Week 3, and Week 5 of each treatment cycle).

Patients will receive 15 µg/kg ALT-803 administered by subcutaneous injection every three weeks (Week 1 and 4 of each treatment cycle).


Experimental: Group B
Patients who are currently receiving PD-1 checkpoint inhibitor therapy and have disease progression after experiencing stable disease for at least six months following previous treatment with PD-1 checkpoint inhibitor therapy.
Drug: ALT-803 + Pembrolizumab

Patients will receive 200 mg pembrolizumab as an intravenous infusion over 30 minutes every three weeks (Week 1 and Week 4 of each treatment cycle).

Patients will receive 15 µg/kg ALT-803 administered by subcutaneous injection every three weeks (Week 1 and 4 of each treatment cycle).


Drug: ALT-803 + Nivolumab

Patients will receive 240 mg nivolumab as an intravenous infusion over 30-60 minutes every two weeks (Week 1, Week 3, and Week 5 of each treatment cycle).

Patients will receive 15 µg/kg ALT-803 administered by subcutaneous injection every three weeks (Week 1 and 4 of each treatment cycle).





Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 24 months ]
    Assess the anti-tumor activity of ALT-803 in combination with either pembrolizumab or nivolumab in patients with advanced or metastatic non-small cell lung cancer who have progressed following an initial response to treatment with PD-1 checkpoint inhibitors.


Secondary Outcome Measures :
  1. Disease-specific Survival [ Time Frame: 24 months ]
    Assess time from first treatment to death resulting from lung cancer.

  2. Overall Survival [ Time Frame: 24 months ]
    Assess time from first treatment to death resulting from any cause.

  3. Time to Response [ Time Frame: 24 months ]
    Assess time to response

  4. Duration of Response [ Time Frame: 24 months ]
    Assess duration of response

  5. Incidence of Adverse Events [ Time Frame: 24 months ]
    Assess incidence of adverse events.

  6. Quality of Life (QOL) [ Time Frame: 24 months ]
    Compare changes in QOL scores from baseline.



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

Inclusion Criteria:

  • Voluntary written informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations
  • Histologically or cytologically confirmed diagnosis of stage III/IV Non-Small Cell Lung Cancer (NSCLC)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Measurable disease by CT or MRI, as defined by RECIST v1.1
  • Current treatment of at least 3 months with pembrolizumab or nivolumab (no more than 1 cycle / 6 weeks of treatment interruption immediately prior to study enrollment)
  • Experienced a previous response to pembrolizumab or nivolumab
  • Patients with genomic tumor aberrations should have received prior treatment with an FDA-approved targeted therapy (if available)
  • Current progressive disease, as defined by RECIST v1.1
  • Adequate organ system function within 14 days of baseline:

    • ANC ≥ 750/µL (≥0.75 x 10^9/L)
    • Platelets ≥ 100,000/µL (≥100 x 10^9/L)
    • Hemoglobin > 8 g/dL
    • Total bilirubin < 2.0 x ULN
    • AST < 3.0 x ULN
    • ALT < 3.0 x ULN
    • eGFR > 45 mL/min
  • Men and women, ≥ 18 years of age
  • Female participants / women of childbearing potential (WOCBP) must adhere to using a medically accepted method of birth control up to 28 days prior to screening and agree to continue its use during the study or be surgically sterilized (e.g., hysterectomy or tubal ligation) and males must agree to use barrier methods of birth control while on study. WOCBP must agree to use effective contraception during treatment and for at least 5 months following the last dose of study treatment.
  • Women of child-bearing potential must have a negative serum pregnancy test during Screening and a negative urine pregnancy test within 24 hours prior to first dose of study treatment. Non-childbearing is defined as greater than one year postmenopausal or surgically sterilized.

Exclusion Criteria:

  • Patients with CNS metastases with the following exceptions:

    • Patient untreated CNS metastases with 4 or fewer sites of disease, with no single site larger than 20mm, are eligible if they are asymptomatic and not requiring steroids at any dose. Patients with asymptomatic CNS metastases may be treated with radiosurgery before or during therapy on trial without treatment delays.
    • Patients with treated, symptomatic CNS metastases are eligible if they are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to registration AND either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).
  • New York Heart Association (NYHA) Class III or IV heart failure, uncontrollable supraventricular arrhythmias, any history of a ventricular arrhythmia, or other clinical signs of severe cardiac dysfunction
  • Symptomatic congestive heart failure, unstable angina pectoris, or myocardial infarction within 6 months of enrollment
  • Known autoimmune disease requiring active treatment.
  • History of interstitial lung disease and/or immune mediated pneumonitis
  • Known HIV-positive
  • Active systemic infection requiring parenteral antibiotic therapy
  • Positive hepatitis C serology or active hepatitis B infection
  • Any ongoing toxicity from prior anti-cancer treatment that, in the judgement of the investigator, may interfere with study treatment. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must resolve to grade 1 (NCI CTCAE version 4) or baseline prior to enrollment. Eligible patients must not require more than 10 mg/day prednisone (or equivalent dose).
  • Previous malignancies (except non-melanoma skin cancers, in situ bladder cancer, in situ gastric or in situ colon cancers, in situ cervical cancers/dysplasia or breast carcinoma in situ) unless a complete remission was achieved at least 1 year prior to study entry and no additional therapy is required or anticipated to be required during the study period
  • No other illness that in the opinion of the investigator would exclude the subject from participating in the study
  • Patients in which treatment with pembrolizumab and nivolumab is contraindicated
  • Patients who have received another investigational agent within the previous 3 months
  • Women who are pregnant or nursing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228667


Contacts
Contact: Amy Rock, PhD 954-443-8600 amyrock@altorbioscience.com
Contact: Liza Hernandez, BS 954-443-8600 lizahernandez@altorbioscience.com

Locations
United States, California
Chan Soon-Shiong Institute for Medicine Recruiting
El Segundo, California, United States, 90245
Contact: Jessica Daly       Jessica.Daly@cssifm.org   
Principal Investigator: Mira Kistler, MD         
Desert Hematology Oncology Medical Group, Inc. Recruiting
Rancho Mirage, California, United States, 92270
Contact: Carolyn Arrieta       carolyndho@aol.com   
Principal Investigator: Luke P Dreisbach, MD         
United States, Missouri
Mercy Research Joplin Recruiting
Joplin, Missouri, United States, 64804
Contact: Esmeralda R Carrillo       Esmeralda.Carrillo@mercy.net   
Principal Investigator: Samir M Dalia, MD         
Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center Recruiting
Springfield, Missouri, United States, 65804
Contact: Pearlena C Hamlet       pearlena.hamlet@mercy.net   
Principal Investigator: Mohan Tummala, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Eleanor Hardy    843-792-4421    hardyel@musc.edu   
Principal Investigator: John Wrangle, MD, MPH         
St. Francis Cancer Center/Bon Secours St. Francis Health System Recruiting
Greenville, South Carolina, United States, 29607
Contact: Melissa F Beckman       melissa_beckman@bshsi.org   
Principal Investigator: Robert Siegel, MD.         
Spartanburg Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Susan Stanley       sstanley@gibbscc.org   
Principal Investigator: Vikas Dembla, MD         
Sponsors and Collaborators
Altor BioScience

Responsible Party: Altor BioScience
ClinicalTrials.gov Identifier: NCT03228667     History of Changes
Other Study ID Numbers: CA-ALT-803-02-17
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Altor BioScience:
Pembrolizumab
Nivolumab
Non-Small Cell Lung Cancer
Immunotherapy
Interleukin-15
PD-1 Checkpoint Inhibitor
ALT-803

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