Melanoma Clinical Trial

A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors

Summary

This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 in participants with advanced solid tumors.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Participants have adequate bone marrow, kidney and liver function.
Participants with a history of chronic heart failure or significant cardiovascular disease must have an echocardiogram or multigated acquisition scan indicating left ventricular ejection fraction greater than or equal to 45% within 28 days prior to the first dose of study drug.
Participants must have creatinine clearance greater than or equal to 50 mL/min as measured by 24-hour urine or estimated by the Cockcroft-Gault formula.
Participants must have total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN), and aspartate aminotransferase and alanine aminotransferase less than or equal to 2.5 times ULN.
Participants in all monotherapy arms must have an advanced solid tumor that has progressed on standard therapies known to provide clinical benefit or the participants are intolerant to such therapies.
Participants in all combination therapy arms must have recurrent or metastatic HNSCC or NSCLC and previously received platinum-based therapy and progressed either during or after anti-programmed death ligand 1 (PDL1)-based therapy. In addition, participants must have received only one prior immunotherapy.
The Sponsor may decide to limit the specific tumor types selected or treatment settings for specific arms based on evidence gathered.

Exclusion Criteria:

Participant must not have an active or prior documented autoimmune disease in the last 2 years.
Participant must not have current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).
Participant must not have a history of primary immunodeficiency, bone marrow transplantation, chronic lymphocytic leukemia, solid organ transplantation, previous clinical diagnosis of tuberculosis, inflammatory bowel disease, interstitial lung disease, or immune-mediated pneumonitis.
Participant must not have a history of clinically significant uncontrolled condition(s) including but not limited to the following: uncontrolled hypertension; symptomatic congestive heart failure; unstable angina pectoris or cardiac arrhythmia including atrial fibrillation.
Participant must not have a history of coagulopathy or a platelet disorder associated with significant clinical risk of thromboembolic event in the judgement of the investigator, or major thromboembolic event within 6 months prior to the first dose of study treatment.
Participant must not have a prior grade greater than or equal to 3 immune-mediated neurotoxicity or pneumonitis while receiving immunotherapy.
Participant must not have a known uncontrolled malignancy of the central nervous system.
Participants in all combination therapy arms must not have a history of exposure to an immunotherapy experiencing an immune-mediated adverse event that required permanent discontinuation of the immunotherapy.
Female participants must not be pregnant, breastfeeding or considering becoming pregnant during the study or for at least 3 or 5 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug.
Male participants must not be considering fathering a child or donating sperm during the study or for at least 3 or 5 months (for monotherapy and combination therapy participants, respectively) after the last dose of study drug.
Participant is judged by the investigator to have evidence of hemolysis.
For Japan only, participants with a history of interstitial lung disease (pneumonitis) or current interstitial lung disease (pneumonitis).

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

163

Study ID:

NCT02988960

Recruitment Status:

Active, not recruiting

Sponsor:

AbbVie

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There are 22 Locations for this study

See Locations Near You

The Angeles Clinic and Researc /ID# 156324
Los Angeles California, 90025, United States
The University of Chicago Medical Center /ID# 155264
Chicago Illinois, 60637, United States
Massachusetts General Hospital /ID# 155267
Boston Massachusetts, 02114, United States
Carolina BioOncology Institute /ID# 155265
Huntersville North Carolina, 28078, United States
Tennessee Oncology-Nashville Centennial /ID# 158654
Nashville Tennessee, 37203, United States
University of Texas MD Anderson Cancer Center /ID# 155263
Houston Texas, 77030, United States
Virginia Cancer Specialists - Fairfax /ID# 155266
Fairfax Virginia, 22031, United States
Peninsula Oncology Centre /ID# 164372
Frankston Victoria, 3199, Australia
Austin Health /ID# 171189
Heidelberg Victoria, 3084, Australia
Princess Margaret Cancer Centre /ID# 200819
Toronto Ontario, M5G 2, Canada
Institut Bergonie /ID# 162665
Bordeaux Gironde, 33000, France
Duplicate_Institut Regional du Cancer /ID# 163609
Montpellier CEDEX 5 Herault, 34298, France
Centre Leon Berard /ID# 162663
Lyon CEDEX 08 Rhone, 69373, France
Institut Gustave Roussy /ID# 162666
Villejuif Cedex Val-de-Marne, 94805, France
National Cancer Center Hospital East /ID# 216870
Kashiwa-shi Chiba, 277-8, Japan
National Cancer Center Hospital /ID# 217758
Chuo-ku Tokyo, 104-0, Japan
Yonsei University Health System Severance Hospital /ID# 166292
Seoul Seoul Teugbyeolsi, 03722, Korea, Republic of
Seoul National University Hospital /ID# 166291
Seoul , 03080, Korea, Republic of
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 200129
Majadahonda Madrid, 28222, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 200128
Madrid , 28040, Spain
Hospital Universitario HM Sanchinarro /ID# 200127
Madrid , 28050, Spain
Hospital Universitario y Politecnico La Fe /ID# 200975
Valencia , 46026, Spain

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

163

Study ID:

NCT02988960

Recruitment Status:

Active, not recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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