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A trial to find out if vidutolimod together with cemiplimab is safe and if it works in adult participants with advanced cancer or metastatic cancer
EU CTIS ID: 2023-507344-36-01
What this study is testing
To determine confirmed objective response rate (ORR) with vidutolimod in combination with cemiplimab per RECIST 1.1 by investigator
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histopathologically-confirmed diagnosis of cancer, as defined by the protocol
- Measurable disease, as defined by RECIST v1.1 and as defined in the protocol
- Adequate organ function based on most recent laboratory values within 3 weeks before first dose of study treatment on Week 1 Day 1 (W1D1), as defined in the protocol
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 at Screening
- Other protocol defined inclusion criteria apply
You likely can't join if
- Received radiation therapy (or other non-systemic therapy) within 2 weeks before first dose of study treatment on W1D1. Participants should have recovered (i.e. Grade ≤ 1 or at baseline) from radiation-related toxicities.
- Active autoimmune disease that required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment.
- NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
- Untreated, symptomatic, or enlarging central nervous system metastases or carcinomatous meningitis (including leptomeningeal metastases from solid tumors).
- Received systemic pharmacologic doses of corticosteroids > 10 mg/day prednisone within 30 days before first dose of study treatment on W1D1, as defined in the protocol.
- History of immune-mediated AE leading to permanent discontinuation due to prior PD-1-blocking antibody.
See the full eligibility criteria
- Histopathologically-confirmed diagnosis of cancer, as defined by the protocol
- Measurable disease, as defined by RECIST v1.1 and as defined in the protocol
- Adequate organ function based on most recent laboratory values within 3 weeks before first dose of study treatment on Week 1 Day 1 (W1D1), as defined in the protocol
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 at Screening
- Other protocol defined inclusion criteria apply
- Received radiation therapy (or other non-systemic therapy) within 2 weeks before first dose of study treatment on W1D1. Participants should have recovered (i.e. Grade ≤ 1 or at baseline) from radiation-related toxicities.
- Active autoimmune disease that required systemic treatment in past 2 years; replacement therapy is not considered a form of systemic treatment.
- NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
- Untreated, symptomatic, or enlarging central nervous system metastases or carcinomatous meningitis (including leptomeningeal metastases from solid tumors).
- Received systemic pharmacologic doses of corticosteroids > 10 mg/day prednisone within 30 days before first dose of study treatment on W1D1, as defined in the protocol.
- History of immune-mediated AE leading to permanent discontinuation due to prior PD-1-blocking antibody.
- Not fully recovered from AEs due to prior treatment (to Grade 1 or less, per Common Terminology Criteria for Adverse Events (CTCAE), with the exception of persistent vitiligo, alopecia, hypothyroidism, diabetes mellitus, and adrenal and/or pituitary insufficiency.
- Active pneumonitis or history of noninfectious pneumonitis that required steroids
- Severe uncontrolled medical disease within 12 months of screening, including but not limited to poorly controlled hypertension, unstable angina, myocardial infarction, congestive heart failure (New York Heart Association Class II or greater), pericarditis, cerebrovascular accident, or implanted or continuous use of a pacemaker or defibrillator, or emphysema with FEV1 ≤ 50% predicted.
- Known history of immunodeficiency.
- Known additional malignancy that is progressing or required active treatment within the past 3 years, as defined in the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.