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PD-L1 Inhibitor
DCR-PDL1 for Cancer
Phase 1
Recruiting
Research Sponsored by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Malignancy not currently amenable to surgical intervention
ECOG performance status of 0, 1, or 2, and an anticipated life expectancy of ≥ 3 months at the time of signing the informed consent
Must not have
Participants with known CNS or leptomeningeal metastases not controlled by prior surgery or radiotherapy, or symptoms suggesting CNS involvement for which treatment is required
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 8
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the safety and how well the body can tolerate a new medication called DCR-PDL1 given through a vein in adult patients with solid tumors. Patients will receive different doses of the
Who is the study for?
This trial is for adults with solid tumors. Participants will be placed into one of four groups to receive increasing doses of DCR-PDL1, given through the veins. Specific eligibility details are not provided, but typically include factors like type and stage of tumor, previous treatments, and overall health.
What is being tested?
The study tests the safety and how well the body handles DCR-PDL1 when administered intravenously in adults with solid tumors. It involves multiple IV doses within treatment cycles, with close monitoring to decide if higher doses can be safely given.
What are the potential side effects?
While specific side effects aren't listed here, common ones for cancer drugs like DCR-PDL1 may include fatigue, nausea, allergic reactions at infusion sites or throughout the body, liver problems (like hepatitis), and potential immune system issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer cannot be removed with surgery.
Select...
I can care for myself and doctors expect me to live at least 3 more months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have brain or spinal cord metastases not managed by surgery or radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline in Vital Signs: Oral, Tympanic, Temporal Artery Temperature
Change From Baseline in Vital Signs: Pulse and Respiratory Rate
Change From Baseline in Vital Signs: Systolic and Diastolic Blood Pressure
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: DCR-PDL1Experimental Treatment1 Intervention
Participants will receive multiple IV doses of DCR-PDL1 during each treatment cycle.
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Who is running the clinical trial?
Dicerna Pharmaceuticals, Inc., a Novo Nordisk companyLead Sponsor
18 Previous Clinical Trials
543 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
141 Previous Clinical Trials
1,355,881 Total Patients Enrolled