Melanoma Clinical Trial

A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors

Summary

To better understand the safety and tolerability of ALKS 4230 in humans

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Full Description

To investigate the safety and tolerability of ALKS 4230, determine the recommended Phase 2 dose (RP2D) and assess anti-tumor activity in Monotherapy and ALKS 4230 in Combination with pembrolizumab.

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Eligibility Criteria

Inclusion Criteria:

For Part A, the subject has histological or cytological evidence of a solid tumor; for Part B, the subject has a diagnosis of melanoma or renal cell carcinoma
All subjects must have advanced solid tumors that have returned after treatment with established approved therapies or be intolerant of established therapies
Subjects enrolled in Part B or Part C must have at least 1 lesion that may qualify as a target lesion
Subject can move around on their own, has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and has an estimated life expectancy of at least 3 months
Subject must have adequate hematologic reserve
Subjects must have adequate liver function
Subjects must have adequate kidney function
Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy or surgery
Subjects who have received investigational agents must wait at least 4 weeks
Females of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and on Day 1 before the first dose is administered. A female not of childbearing potential is one who has undergone bilateral oophorectomies or who is postmenopausal, defined as >45 years of age and without a menstrual period for 12 consecutive months
Meets contraceptive requirements defined in the protocol
Additional criteria may apply

Exclusion Criteria:

Subject is currently pregnant or breastfeeding, or is planning to become pregnant during the study
Subjects with an active infection or with a fever >/= 38.5 degrees C within 3 days of the first scheduled day of dosing for Cycle 1
Subjects with active or symptomatic central nervous system metastases are excluded. Subjects with central nervous system metastases are eligible for the study if the metastases have been treated by surgery and/or radiation therapy, the subject is off corticosteroids for at least 2 weeks and the subject is neurologically stable
Subjects have a mean QT interval corrected by the Fridericia Correction formula value of >470 msec (in females) or >450 msec (in males)
Subjects with known hypersensitivity to any components of ALKS 4230
Subjects with known hypersensitivity to any components of pembrolizumab (for patients in combination arm only)
Subjects who require pharmacologic doses of corticosteroids; replacement doses, topical, ophthalmologic, and inhalational steroids are permitted
Subjects who developed autoimmune disorders while on prior immunotherapy, including pneumonitis, nephritis, and neuropathy
Subjects with any other concurrent uncontrolled illness, including mental illness or substance abuse, which may interfere with the ability of the subject to cooperate and participate in the study
The subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B or C, or active tuberculosis, or has a known history of tuberculosis
Subjects with dyspnea at rest of requiring oxygen therapy
Subjects active autoimmune disease requiring systemic treatment within the past 30 days
Subjects who received radiotherapy within the last 4 weeks before start of study treatment administration with the exception of limited field palliative radiotherapy
Subjects who have received systemic immunomodulatory agents within 28 days prior to C1D1.
Subjects who have received administration of a live, attenuated vaccine within 4 weeks of Cycle 1, Day1.
Prior solid organ and/or non-autologous hematopoietic stem cell or bone marrow transplant recipients
Subjects who have received prior IL-2 based or IL-15 based cytokine therapy
Additional criteria may apply

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

243

Study ID:

NCT02799095

Recruitment Status:

Completed

Sponsor:

Mural Oncology, Inc

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There are 27 Locations for this study

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Mural Oncology Investigational Site
Denver Colorado, 80045, United States
Mural Oncology Investigational Site
Port Saint Lucie Florida, 34952, United States
Mural Oncology Investigational Site
Tampa Florida, 33610, United States
Mural Oncology Investigational Site
Lexington Kentucky, 40536, United States
Mural Oncology Investigational Site
Boston Massachusetts, 02215, United States
Mural Oncology Investigational Site
Detroit Michigan, 47201, United States
Mural Oncology Investigational Site
Buffalo New York, 14203, United States
Mural Oncology Investigational Site
New York New York, 10016, United States
Mural Oncology Investigational Site
Cleveland Ohio, 44106, United States
Mural Oncology Investigational Site
Dallas Texas, 75230, United States
Mural Oncology Investigational Site
Fairfax Virginia, 22031, United States
Mural Oncology Investigational Site
Spokane Washington, 99208, United States
Mural Oncology Investgational Site
Albury New South Wales, 2640, Australia
Mural Oncology Investigational Site
Waratah New South Wales, 2298, Australia
Mural Oncology Investigational Site
Brussels MO, 1200, Belgium
Mural Oncology Investigational Site
Kortrijk West-Vlaanderen, 8500, Belgium
Mural Oncology Investigational Site
Edmonton Alberta, , Canada
Mural Oncology Investigational Site
Hamilton Ontario, , Canada
Alkermes Investigational Site
Toronto Ontario, , Canada
Mural Oncology Investigational Site
Montréal Quebec, , Canada
Mural Oncology Investigational Site
Québec Quebec, G1R 2, Canada
Mural Oncology Investigational Site
Daejeon , 35015, Korea, Republic of
Mural Oncology Investigational Site
Seoul , 02841, Korea, Republic of
Mural Oncology Investigational Site
Seoul , 03722, Korea, Republic of
Mural Oncology Investigational Site
Skorzewo Poznan, 60-18, Poland
Mural Oncology Investigational Site
Barcelona , 8036, Spain
Mural Oncology Investigational Site
Madrid , 28033, Spain
Mural Oncology Investigational Site
Madrid , 28040, Spain
Mural Oncology Investigational Site
Madrid , 28041, Spain
Mural Oncology Investigational Site
Madrid , 28050, Spain
Mural Oncology Investigational Site
Valencia , 46010, Spain

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

243

Study ID:

NCT02799095

Recruitment Status:

Completed

Sponsor:


Mural Oncology, Inc

How clear is this clinincal trial information?

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