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Study of AM0010 With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Patients With Metastatic Non-Small Cell Lung Cancer (Cypress 1)

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ClinicalTrials.gov Identifier: NCT03382899
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 pembrolizumab versus pembrolizumab 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: Pembrolizumab 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 Pembrolizumab versus Pembrolizumab alone in patients with stage IV / metastatic wild type Non-Small Cell Lung Cancer and tumors with high expression of PD-L1 (> 50%)

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 Pembrolizumab vs. Pembrolizumab Alone as First-Line (1L) Therapy in Patients With Stage IV / Metastatic Wild Type (WT) Non-Small Cell Lung Cancer and Tumors With High Expression of PD-L1 (> 50%)
Actual Study Start Date : February 22, 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

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]). Pembrolizumab will be administered as intravenous (IV) infusion on Day 1 of a 21-day cycle (200mg over 30 minutes (± 10min))
Biological: AM0010
AM0010 plus Pembrolizumab

Drug: Pembrolizumab
Pembrolizumab Alone

Active Comparator: 2
Pembrolizumab will be administered as an intravenous (IV) infusion on Day 1 of a 21-day cycle (200mg over 30 minutes (± 10min))
Drug: Pembrolizumab
Pembrolizumab 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



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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 with tumor tissue high expression of PD-L1 as defined by Tumor Proportion Score (TPS) ≥ 50%
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  4. Patients with measurable disease by spiral CT or MRI per RECIST v.1.1 criteria.
  5. Patients that have completed prior radiotherapy or radiosurgery at least 2 weeks prior to randomization.
  6. Patients must be naïve to therapy for the advanced stage of the disease. Previous neoadjuvant or adjuvant therapy is allowed for patients who successfully underwent complete radical surgery and ONLY if the last treatment was administered more than 12 months prior to the start of the trial treatment

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 pembrolizumab
  5. Patients with a history of severe hypersensitivity reactions to monoclonal antibodies
  6. Pregnant or lactating women
  7. Patients receiving any investigational agent within 28 days of first administration of trial treatment
  8. Patients that have received therapy with anti-tumor vaccines or other immunostimulatory antitumor agents
  9. 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

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): NCT03382899


Contacts
Contact: Study Director 650-771-9325 Cypress1@armobio.com

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Sponsors and Collaborators
ARMO BioSciences

Responsible Party: ARMO BioSciences
ClinicalTrials.gov Identifier: NCT03382899     History of Changes
Other Study ID Numbers: AM0010-201
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
Pembrolizumab
Antineoplastic Agents