ACTIVE_NOT_RECRUITING

Non-randomized, Open-label Study of Intralesional Nivolumab for High Risk Oral Premalignant Lesions

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To characterize the safety and tolerability of nivolumab injected intralesionally in patients with high-risk oral premalignant lesions.

Official Title

Pilot, Non-randomized, Open-label Study of Intralesional Nivolumab for High Risk Oral Premalignant Lesions

Quick Facts

Study Start:2022-09-13

Study Completion:2027-02-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05327270

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Presence of a treatment naïve, biopsy proven, intraoral premalignant lesion visible from oral cavity. 2. Be willing and able to provide written informed consent for the trial. 3. Be \>/= 18 years of age on day of signing informed consent. 4. Be willing to provide tissue, either archive or from a newly obtained oral biopsy. 5. Have a performance status of 0-2 on the ECOG Performance Scale. 6. Demonstrate adequate organ function as defined in Table 1 7. Female subject of childbearing potential should have a negative urine or serum pregnancy test 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. 8. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of study therapy through 120 days after the last dose of Nivolumab. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year. 9. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.	1. Is currently participating and receiving study therapy with potential anti-neoplastic activity or has participated in a study of an investigational agent and received study therapy with potential anti-neoplastic activity within 4 weeks of the first dose of treatment. 2. Has a known history of active TB (Bacillus Tuberculosis) 3. Hypersensitivity to nivolumab or any of its excipients. 4. 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 2 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. 5. 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 2 or at baseline) from adverse events due to a previously administered agent. 6. Has a known additional malignancy that is progressing or requires active treatment other than adjuvant hormonal therapy. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin or in situ cervical cancer. 7. Has known history of, or any evidence of active, non-infectious pneumonitis. 8. Has an active infection requiring systemic therapy. 9. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 10. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 11. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of treatment with pembrolizumab, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. 12. Has received a live vaccine within 30 days of planned start of study therapy.

Inclusion Criteria

Exclusion Criteria

1. Presence of a treatment naïve, biopsy proven, intraoral premalignant lesion visible from oral cavity.
2. Be willing and able to provide written informed consent for the trial.
3. Be \>/= 18 years of age on day of signing informed consent.
4. Be willing to provide tissue, either archive or from a newly obtained oral biopsy.
5. Have a performance status of 0-2 on the ECOG Performance Scale.
6. Demonstrate adequate organ function as defined in Table 1
7. Female subject of childbearing potential should have a negative urine or serum pregnancy test 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.
8. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of study therapy through 120 days after the last dose of Nivolumab. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.
9. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.

1. Is currently participating and receiving study therapy with potential anti-neoplastic activity or has participated in a study of an investigational agent and received study therapy with potential anti-neoplastic activity within 4 weeks of the first dose of treatment.
2. Has a known history of active TB (Bacillus Tuberculosis)
3. Hypersensitivity to nivolumab or any of its excipients.
4. 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 2 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
5. 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 2 or at baseline) from adverse events due to a previously administered agent.
6. Has a known additional malignancy that is progressing or requires active treatment other than adjuvant hormonal therapy. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin or in situ cervical cancer.
7. Has known history of, or any evidence of active, non-infectious pneumonitis.
8. Has an active infection requiring systemic therapy.
9. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
10. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
11. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of treatment with pembrolizumab, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
12. Has received a live vaccine within 30 days of planned start of study therapy.

Contacts and Locations

Principal Investigator

Moran Amit, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Moran Amit, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-13

Study Completion Date2027-02-02

Study Record Updates

Study Start Date2022-09-13

Study Completion Date2027-02-02

Terms related to this study

Additional Relevant MeSH Terms

Head and Neck Cancer