CompletedPhase 1/2

Pembrolizumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma

United States26 participantsStarted 2017-10-31

Plain-language summary

This is a Phase I/Ib investigator-initiated open label of the combination of VESANOID and pembrolizumab treatment.

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Diagnosis of advanced melanoma (unresectable Stage III or Stage IV Melanoma).
✓. Planned standard treatment with pembrolizumab.
✓. Be willing and able to provide written informed consent for the trial.
✓. State willingness to comply with all study procedures and be available for the duration of the trial.
✓. Be ≥ 18 years of age on day of signing informed consent.
✓. Have a performance status of 0 or 1 on the ECOG Performance Scale.
✓. Demonstrate adequate organ function as defined in Table 1 of the protocol.
✓. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Exclusion criteria

✕. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
✕. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
✕. Has a known history of active TB (Bacillus Tuberculosis).
✕. Hypersensitivity to pembrolizumab or any of its excipients.
✕. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
✕. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. Subjects with chronic conditions such as vision changes from plaque radiation therapy for ocular melanoma or prior hearing loss that is not reasonably expected to be exacerbated by the investigational product may be included.
✕. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
✕. Has active autoimmune 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 not considered a form of systemic treatment.

What they're measuring

Maximally Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of Pembrolizumab

Timeframe: 21 days from first dose of combined treatment

Maximally Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of All-Trans Retinoic Acid

Timeframe: 21 days from first dose of combined treatment

Trial details

NCT IDNCT03200847

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-20

Results submitted2023-01-04

View on ClinicalTrials.gov More Stage IV Melanoma trials