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ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell After Progression on Anti-PD-(L)1

ConditionsMerkel Cell CarcinomaMerkel Cell Carcinoma, Stage IIIMerkel Cell Carcinoma, Stage IV
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison

About this trial

The goal of this clinical trial is to learn if ASTX727 can be combined with retifanlimab to treat Merkel cell cancer. It will also learn about the safety of combining these drugs. The main questions it aims to answer are:

* Can the combination shrink cancer and lower the chance of the cancer growing or spreading? * Is the combination better than standard of care for Merkel cell cancer?

Participants will:

* Take oral ASTX727 and retifanlimab through a vein in the arm for about 2 years. * Visit the clinic once every 2 weeks for checkups and tests

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals age ≥ 18 years at the time of consent

ECOG Performance Status of 0-2

Histological or cytological evidence/confirmation of Merkel cell carcinoma (MCC)

Must have unresectable stage III/IV MCC per American Joint Committee on Cancer (AJCC) 8th edition. Participants must be considered unresectable based on the judgment of the treating physician

Disqualifiers

Prior treatment with a hypomethylating agent (HMA) (e.g., azacitidine, decitabine, guadecitabine)

History of clinically significant intolerance, hypersensitivity, or treatment discontinuation of an anti-PD-1 or anti-PD-L1 inhibitor due to grade 3 or greater immune-related adverse events (irAEs). Participants who are able to be successfully rechallenged with anti-PD-(L)1 inhibitor without recurrence of grade 3 or greater irAEs are permitted on study. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study drug(s) may be included (e.g. hearing loss, hypothyroidism, adrenal insufficiency, type 1 diabetes, or other endocrinopathies) after consultation with the sponsor investigator

Palliative radiation therapy administered within 1 week before the first dose of study treatment or radiation therapy in the thoracic region that is > 30 Gy within 6 months before the first dose of study treatment

Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration

Trial design

Design model

Single group

Treatments tested in this trial

  • ASTX727 + retifanlimab

    Drug

    Participants take oral ASTX727 and receive retifanlimab through a vein

Treatment groups

31 Participants
are divided into 1 treatment group
Group A: Merkel cell carcinomaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of subjects with treatment-emergent adverse events

Adverse events will be measured using NCI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Grade 3 or greater non-hematological, grade 4 or greater treatment-emergent AEs, and instances where treatment has to be discontinued will be calculated for this measure.

Time frame
Up to 27 months (2 years plus 90 days)

Secondary outcomes

1

Overall Response Rate (ORR)

ORR is defined as the proportion of subjects who have a partial response \[PR\] or complete response \[CR\] per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (1.1).

Time frame
Up to 4 years
2

Disease Control Rate (DCR)

DCR is defined as the proportion of all subjects with RECIST-based PR, CR, and SD divided by the total number of evaluable participants.

Time frame
Up to 4 years
3

Progression-free Survival (PFS)

PFS is defined as the interval from start of treatment to first documentation of disease progression per RECIST 1.1 or death from any cause. Participants who have not progressed will be right-censored at the date of the last disease evaluation

Time frame
Up to 4 years
4

Overall Survival (OS)

OS is defined as the interval from start of treatment to death of any cause. Participants alive at last time of contact will be right-censored.

Time frame
Up to 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: