A Phase 1/2 Study of ALKS 4230 Administered Subcutaneouslyas Monotherapy and in Combination With Pembrolizumab inSubjects With Advanced Solid Tumors(ARTISTRY-2)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 257

Inclusion Criteria

- Eligible subjects must be aged =18 years.
- For Phase 1, subjects must have an advanced solid tumor (including lymphoma) and progressive disease following at least 1 line of therapy.
- For Phase 2, subjects will be enrolled into 1 of 5 cohorts based on the subject’s tumor type and specific histology: NSCLC, SCCHN , squamous tumor agnostic, HCC, and SCLC.
- All study subjects in Phase 1 and Phase 2 must have measurable disease based on RECIST and an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1. Subjects must have adequate hematologic reserves and adequate hepatic and renal function.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 77

Exclusion Criteria

1. Subject is currently pregnant or breastfeeding or is planning to become pregnant during the study period.
2. Subject is employed by Alkermes, Syneos Health, the Investigator, the study center (including permanent or temporary contact workers and designees responsible for the conduct of the study), or other affiliate of this study or is immediate family of an employee of Alkermes, Syneos Health, the Investigator, the study center, or other affiliate. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
3. Subject has an active infection or a fever =38.5°C (=101°F) within 3 days of the first scheduled day of dosing for the monotherapy lead-in or Cycle 1 of Phase 2.
4. Subject has known hypersensitivity (Grade =3) to any components of ALKS 4230, to pembrolizumab, or any of its excipients.
5. Subjects with mean QT interval corrected by the Fridericia Correction Formula values of >470 msec (in females) or >450 msec (in males) following a standard 12-lead electrocardiogram (ECG); subjects who are known to have congenital prolonged QT syndromes; or subjects who are on medications known to cause prolonged QT interval on ECG.
6. Subject has developed autoimmune disorders while on prior immunotherapy, including pneumonitis, nephritis, and neuropathy. Subject was discontinued from prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, or CD137) due to a Grade 3 or higher immune-related AE.
Subjects who developed other autoimmune disorders of Grade =3 may enroll if the disorder has resolved and the subject is off steroids for 2 weeks. Subjects who experienced autoimmune colitis as a toxicity of prior immunotherapy must undergo or must have been evaluated by colonoscopy to rule out ongoing inflammation.
7. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
8. Subject has active or symptomatic central nervous system metastases unless the metastases have been treated by surgery and/or radiation therapy, the subject has been dose, and the subject is neurologically stable.
9. Subject has an active autoimmune disease that has required systemic treatment in the past 2 years (ie, with the use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
10. Subject is known to be positive for human immunodeficiency virus and/or history of hepatitis B, or C infections or is known to be positive for hepatitis B antigen (HBsAg)/hepatitis B virus (HBV) DNA or hepatitis C antibody (Hep C Ab) or RNA.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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