CompletedPhase 1

CAVATAK® and Ipilimumab in Uveal Melanoma Metastatic to the Liver (VLA-024 CLEVER)

United States11 participantsStarted 2018-01-29

Plain-language summary

This is an open-label Phase 1b clinical study of ipilimumab in combination with intravenous CVA21 in subjects who have uveal melanoma metastatic to liver.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Histologic or cytologically confirmed diagnosis of uveal melanoma with measurable disease (based on RECIST 1.1 criteria) in the liver (by CT, PET/CT or MRI) at the time of screening.
✓. Patients that have had prior treatment must show disease progression during or following the last treatment according to RECIST 1.1 criteria.
✓. Men and women ≥ 18 years of age.
✓. The subject has a life expectancy of greater than 12 weeks.
✓. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
✓. Adequate organ function as defined by and obtained within 28 days of starting treatment:
✓. Prior therapy with an immune checkpoint inhibitor therapy is allowable. A 6-week washout period will be required for those with prior PD-1 or PD-L1 treatment.
✓. Female subjects of child-bearing potential must have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study medication. If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Exclusion criteria

✕. The subject is a candidate for surgery or loco-regional treatment with curative intent.
✕. Subjects with active (i.e. symptomatic or growing) central nervous system (CNS) metastases. Subjects with CNS metastases are eligible if the metastases have been treated with surgery and/or radiotherapy, the subject is off corticosteroids for at least 2 weeks and the subject is neurologically stable.
✕. Known additional malignancy that is progressing or requires active treatment. Exceptions include cutaneous squamous cell or basal cell carcinoma that has undergone potentially curative therapy or in-situ cervical cancer.
✕. Known history of Human Immunodeficiency Virus (HIV, HIV 1/2 antibodies), known active Hepatitis B (e.g. HBsAg reactive) or Hepatitis C (e.g. HCV RNA \[qualitative\] is detected).
✕. Current systemic steroid therapy other than physiologic replacement (i.e. prednisone ≤ 10 mg or equivalent). Inhaled or topical steroid use is allowed.
✕. Active auto-immune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed.
✕. Active colitis or previous immune-mediated colitis that has not resolved to grade 1 or less.
✕. Chemotherapy, targeted small molecule therapy, radiation therapy, hormonal treatment or immunotherapy within 21 days prior to initiation of treatment. A 6-week washout period will be required for those with prior PD-1 or PD-L1 treatment. Subjects must have resolution of toxic effect(s) of the most recent therapy to Grade 1 or less. Exceptions are subjects with ≤ Grade 2 alopecia or ≤ Grade 2 neuropathy who are permitted in the study. If the subject received major surgery or radiation therapy of \>30 Gy, they must have recovered from the toxicity and/or any complications from the intervention.

What they're measuring

Incidence of treatment-related adverse events as assessed using the current NCI-CTCAE.

Timeframe: 30 days from the last administration of study treatment

Trial details

NCT IDNCT03408587

SponsorViralytics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-05-22

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