Spots Global Cancer Trial Database for A Study of NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
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Trial Identification
Brief Title: A Study of NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Official Title: A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors (ALKOVE-1)
Study ID: NCT05384626
Interventions
Study Description
Brief Summary: Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-655, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors. Phase 1 will evaluate the overall safety and tolerability of NVL-655 and will determine the RP2D and, if applicable, the MTD of NVL-655 in patients with advanced ALK+ solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-655 at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of NVL-655 in patients with advanced ALK-positive NSCLC and other solid tumors.
Detailed Description: In Phase 2, study patients will be enrolled into 6 distinct cohorts: * Cohort 2a: Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement who have received 1 prior 2nd-generation ALK TKI (ceritinib, alectinib, or brigatinib). Up to 2 prior lines of chemotherapy and/or immunotherapy are allowed. * Cohort 2b: Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who have received 2-3 prior ALK TKIs (crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib). Up to 2 prior lines of chemotherapy and/or immunotherapy are allowed. * Cohort 2c: Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who have received lorlatinib as the only prior ALK TKI therapy. Up to one prior line of chemotherapy and/or immunotherapy received prior to lorlatinib is allowed. * Cohort 2d: Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, who are naïve to ALK TKI therapy. Up to one prior line of chemotherapy and/or immunotherapy is allowed. * Cohort 2e: Patients with locally advanced or metastatic NSCLC harboring an ALK rearrangement, not eligible for other Phase 2 cohorts. * Cohort 2f: Patients with other solid tumors harboring an ALK rearrangement or activating ALK mutation, who have received ≥1 prior systemic anticancer therapy, or for whom no satisfactory standard therapy exists.
Keywords
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California Irvine Medical Center, Orange, California, United States
University of California, Davis Comprehensive Cancer Center, Sacramento, California, United States
Stanford Cancer Institute, Stanford, California, United States
University of Colorado Cancer Center, Denver, Colorado, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
University of Miami; Sylvester Cancer Center, Miami, Florida, United States
John Hopkins University, Baltimore, Maryland, United States
Mass General Hospital, Boston, Massachusetts, United States
Henry Ford Cancer Institute, Detroit, Michigan, United States
Washington University School of Medicine Siteman Cancer Center, Saint Louis, Missouri, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
OSU Brain & Spine Hospital, Columbus, Ohio, United States
Sarah Cannon, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
Royal North Shore Hospital, Saint Leonards, New South Wales, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Cross Cancer Institute, Edmonton, Alberta, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Centre Leon Berard, Lyon, , France
Chu De Nantes, Saint-Herblain, , France
Institut Claudius Regaud, Toulouse Cedex, , France
Institute Gustave Roussy, Villejuif, , France
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital, Seoul, Seoul Capital, Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, Seoul Capital, Korea, Republic of
National Cancer Centre Singapore, Singapore, , Singapore
Complejo Hospitalario Universitario de A Coruna, A Coruña, , Spain
UOMI Cancer Center, Barcelona, , Spain
Vall d'Hebron, Barcelona, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Royal Marsden Hospital, Sutton, Surrey, United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Contact Details
Name: Viola Zhu, MD, PHD
Affiliation: Nuvalent Inc.
Role: STUDY_DIRECTOR
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