Study of Tilsotolimod with Nivolumab and Ipilimumab for Treating Solid Tumors (ILLUMINATE-206)
Sponsor: Idera Pharmaceuticals, Inc.
ClinicalTrials ID:NCT03865082
This clinical trial is exploring the effectiveness of a new treatment combining tilsotolimod with two immunotherapy drugs, nivolumab and ipilimumab, for patients with various solid tumors.
Patient Parameters
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Program Overview
The purpose of this Phase 2 study is to test a new treatment approach using tilsotolimod, an investigational drug, in combination with two immunotherapy drugs, nivolumab and ipilimumab, to see if it can help treat certain solid tumors. The study is open-label, meaning both the researchers and participants know what treatment is being given, and it takes place at multiple centers.
Description
This study is designed to evaluate the combination of tilsotolimod, nivolumab, and ipilimumab for treating specific solid tumors. Participants will receive these drugs directly into their tumors and will be monitored to see how well the treatment works and if it is safe. The study is open to adults aged 18 and older who meet certain health criteria and have at least one tumor that can be injected and biopsied. Participants must have good organ function and agree to use effective birth control if they are of childbearing potential. Those who have had certain previous cancer treatments may need to consult with the study's Medical Monitor before joining.
Eligibility Criteria
Inclusion Criteria
- Willing and able to sign informed consent and follow study requirements.
- Aged 18 or older.
- Have at least one tumor that can be injected and biopsied.
- Good overall health with a performance status of 0 or 1 and a life expectancy of at least 4 months.
- Adequate organ function based on specific blood tests.
- Women and men with partners of childbearing potential must use effective contraception.
- For those with a history of certain cancer treatments, consultation with the study's Medical Monitor is required.
Additional Criteria for MSS CRC IO Naïve:
- Have advanced, metastatic, or progressive MSS colorectal cancer confirmed by biopsy.
- Have received two prior lines of therapy for advanced or metastatic colorectal cancer.
- Show radiologic progression during or after previous chemotherapy.
Exclusion Criteria
- Must have completed or stopped any previous cancer treatments before joining.
- History of certain lung diseases, autoimmune diseases, or HIV infection.
- Previous treatment with TLR9 agonists, except topical ones.
- Allergic to any study drug components.
- Use of certain herbal or traditional medicines within two weeks before treatment.
- Active infections requiring antibiotics or active hepatitis A, B, or C.
- Pregnant or breastfeeding women.
- Severe allergic reactions to human antibodies.
- Unstable heart conditions or significant heart disease.
- Recent live vaccine administration.
Additional Criteria for MSS CRC IO Naïve:
- Previous treatment with certain immunotherapy drugs.
- Have BRAF V600E mutations.
- History of immune-related colitis.
- Have received three or more lines of therapy for advanced or metastatic colorectal cancer.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Banner University Medical Center Tucson Campus | 85719 | Tucson | Arizona |
| University of Southern California/ Hoag Hospital Presbyterian | 92663 | Newport Beach | California |
| MD Anderson Cancer Center | 77030 | Houston | Texas |
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