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Study of AM0010 With Nivolumab Compared to Nivolumab Alone Second-line Tx in Patients With Metastatic Non-Small Cell Lung Cancer (Cypress 2)

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ClinicalTrials.gov Identifier: NCT03382912
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
ARMO BioSciences

Brief Summary:
To compare the efficacy of AM0010 in combination with nivolumab versus nivolumab alone in patients with metastatic Non-Small Cell Lung Cancer as measured by objective response rate

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Biological: AM0010 Drug: Nivolumab Phase 2

Detailed Description:
This is an open-label, multi-center, randomized, Phase 2 study designed to compare the efficacy and safety of AM0010 in combination with Nivolumab versus Nivolumab alone in patients with stage IV / metastatic wild type Non-Small Cell Lung Cancer and tumors with low tumor expression of PD-L1 (0-49%)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Trial of AM0010 in Combination With Nivolumab vs. Nivolumab Alone as Second-Line Therapy in Subjects With Stage IV / Metastatic Wild Type Non-Small Cell Lung Cancer and Low Tumor Expression of PD-L1
Actual Study Start Date : March 14, 2018
Estimated Primary Completion Date : September 27, 2019
Estimated Study Completion Date : March 25, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: 1
AM0010 self-administered as a SQ injection QD (≤ 80kg body weight = 0.8mg or [0.2mL] > 80kg body weight = 1.6mg [0.4mL]). Nivolumab will be administered as intravenous (IV) infusion on Day 1 of a 14-day cycle (240mg over 30 minutes (± 10min))
Biological: AM0010
AM0010 plus Nivolumab

Drug: Nivolumab
Nivolumab Alone

Active Comparator: 2
Nivolumab will be administered as an intravenous (IV) infusion on Day 1 of a 14-day cycle (240mg over 30 minutes (± 10min))
Drug: Nivolumab
Nivolumab Alone




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 36 months after the last patient randomized ]
    The primary endpoint of this study is ORR defined as the proportion of patients who achieve a CR or PR as assessed by RECIST v.1.1.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 36 months after the last patient randomized ]
    OS defined as the time from date of randomization to death due to any cause

  2. Progression Free Survival [ Time Frame: 36 months after the last patient randomized ]
    PFS defined as the time from date of randomization to the earlier of first documentation of disease progression or death due to any cause



Information from the National Library of Medicine

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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:

  1. Patients must have histologically or cytologically confirmed WT NSCLC that is stage IV / metastatic or recurrent
  2. Patients must have received at least one prior systemic therapy that was not an anti-PD-1, anti-PD-L1 and/or anti-CTLA-4 treatment for the advanced stage of the disease
  3. Patients with tumor tissue low expression of PD-L1 as defined by Tumor Proportion Score (TPS) 0% - 49%
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  5. Patients with measurable disease by spiral computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumor (RECIST) v.1.1 criteria
  6. Patients that have completed prior radiotherapy or radiosurgery at least 2 weeks prior to randomization

Exclusion Criteria:

  1. Patients with active central nervous system (CNS) metastases or carcinomatous meningitis
  2. Patients with any serious or uncontrolled medical disorder or active infection with the hepatitis virus or the human immunodeficiency virus (HIV)
  3. Patients with Grade 1 (NCI-CTCAE v.4.03) toxicities attributed to prior anti-cancer therapy (other than alopecia and fatigue) prior to randomization
  4. Patients that have received nivolumab
  5. Patients that have received therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents
  6. Patients with a history of severe hypersensitivity reactions to monoclonal antibodies
  7. Patients that have received therapy with anti-PD-1, anti-PD-L1, anti-PD-L-2, anti-CD-137, and/or anti CTLA-4 antibodies
  8. Patients receiving any investigational agent within 28 days of first administration of trial treatment
  9. Pregnant or lactating women

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): NCT03382912


Contacts
Contact: Study Director 650-771-9325 Cypress2@armobio.com

  Show 73 Study Locations
Sponsors and Collaborators
ARMO BioSciences

Responsible Party: ARMO BioSciences
ClinicalTrials.gov Identifier: NCT03382912     History of Changes
Other Study ID Numbers: AM0010-202
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018

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

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
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs