Neoadjuvant Trial of Nivolumab in Combination With HF10 Oncolytic Viral Therapy in Resectable Stage IIIB, IIIC, IVM1a Melanoma
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|ClinicalTrials.gov Identifier: NCT03259425|
Recruitment Status : Active, not recruiting
First Posted : August 23, 2017
Results First Posted : October 10, 2019
Last Update Posted : October 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Nivolumab Drug: HF10||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a single-arm, open label, Phase II|
|Masking:||None (Open Label)|
|Official Title:||Phase II Neoadjuvant Trial of Nivolumab in Combination With HF10 Oncolytic Viral Therapy in Resectable Stage IIIB, IIIC, IVM1a Melanoma (Neo-NivoHF10)|
|Actual Study Start Date :||December 21, 2017|
|Actual Primary Completion Date :||September 21, 2018|
|Estimated Study Completion Date :||September 2020|
|Experimental: Nivolumab and HF10, all patients||
Nivolumab at a dose of 240 mg given as an IV infusion starting on day 0. It will be given every 14 days for a total of 7 infusions; Then patient will undergo surgery. Nivolumab will then be administered at a flat dose of 480 mg IV every 28 days for up to one year.
Other Name: OPDIVO
1 x 107th TCID50/mL, intratumoral injection to a single or multiple eligible tumors for a total of 5 mL; on days 0, 7, 14, 21, 28, 42, 56, 70, 84 for a total of 9 injections. All eligible tumors except one will be treated with HF10 up to the maximum volume allowed. The untreated tumor will be used as an untreated control lesion.
- Pathological Response [ Time Frame: 12 weeks ]Following 12 weeks of neoadjuvant treatment with nivolumab and HF10, patients underwent definitive surgery. A percent viable tumor was assessed semi-quantitatively in the definitive surgical resection specimen by estimating the proportion of residual tumor in relation to the total tumor area and reported as percentage viability. A pathologic complete response was defined as no viable residual melanoma cells in the surgical specimen. A major pathologic response was defined as <50% viable tumor cells. A minor pathologic response was defined as 50% or greater viable tumor cells, including specimens that had 100% viability at surgery.
- Recurrence-free Survival [ Time Frame: 1 year post surgery ]Recurrence after surgery will be assessed by radiologic scans scheduled per section 8 and confirmed by biopsy.
- Overall Survival [ Time Frame: 2 years (1 year after stopping 1 year of Nivolumab) ]patients will be followed for survival for one year after completion of adjuvant nivolumab
- Complete Surgical Resection [ Time Frame: Within 28 days after Day 84 ]patients will be assessed at surgery to determine if complete surgical resection was achievable after neo-adjuvant treatment with nivolumab and HF10.
- Rate of Adverse Events for Patients While Taking Nivolumab and HF10 [ Time Frame: Patient safety will be evaluated throughout the treatment period and follow up (Treatment with HF10 is expected to last for 84 days, treatment with nivolumab is expected to last 1 year for each patient after surgery and follow up for 1 year ]patients will be monitored for adverse events related to nivolumab and HF10 using CTCAE criteria
- Radiographic Response Per RECIST 1.1 [ Time Frame: 12 weeks from baseline to surgery ]Patients will be assessed radiographically with CT or MRI scan or assessed clinically.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259425
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|