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PD-L1 Inhibitor
NT-I7 + Atezolizumab for High-Risk Skin Cancer
Phase 1 & 2
Waitlist Available
Led By Brian Gastman, MD
Research Sponsored by NeoImmuneTech
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be ≥18 years of age on day of signing informed consent document
Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 56 months
Awards & highlights
Study Summary
This trial is testing whether adding NT-I7 to atezolizumab helps patients with high-risk melanoma, MCC, or cSCC who haven't responded to anti-PD-1/PD-L1 treatment or who have relapsed.
Who is the study for?
Adults with high-risk skin cancers like melanoma, Merkel Cell Carcinoma, or cutaneous Squamous Cell Carcinoma. Suitable for those who haven't tried anti-PD-1/PD-L1 drugs or whose cancer returned after such treatments. Must be in good health overall and have a decent performance status.Check my eligibility
What is being tested?
The trial is testing if adding NT-I7 to atezolizumab improves outcomes for patients with certain types of skin cancer that are either new to treatment with anti-PD-1/PD-L1 drugs or have not responded well to them.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, fatigue, infusion-related symptoms, and increased risk of infections. The exact side effects can vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 56 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 56 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and Tolerability of NT-I7 in combination with atezolizumab to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of NT-I7
Secondary outcome measures
Preliminary assessment of the Objective Response Rate (ORR) of NT-I7 in combination with atezolizumab
Preliminary assessment the Disease Control Rate (DCR) of NT-I7 in combination with atezolizumab
Preliminary assessment the Duration of Objective Response (DOR) of NT-I7 in combination with atezolizumab
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Checkpoint Inhibitor-Relapsed/Refractory cSCC MCC Melanoma PtsExperimental Treatment2 Interventions
Anti-PD-1/PD-L1 relapsed/refractory patients with cSCC, MCC and melanoma
Group II: Checkpoint Inhibitor-Naive cSCC, MCC PtsExperimental Treatment2 Interventions
Anti-PD-1/PD-L1 naïve patients with cSCC and MCC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Find a Location
Who is running the clinical trial?
NeoImmuneTechLead Sponsor
10 Previous Clinical Trials
476 Total Patients Enrolled
Immune Oncology NetworkUNKNOWN
1 Previous Clinical Trials
14 Total Patients Enrolled
NgocDiep Le, MD, PhDStudy ChairNeoImmuneTech, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active tuberculosis.You have a history of autoimmune disease.I have a history of lung conditions but not active lung inflammation.I have MCC, cSCC, or melanoma that didn't respond well to anti-PD-1/L1 treatment.I have a serious heart condition.I haven't had major surgery in the last 28 days and don't expect to need one during the study.I haven't had chemotherapy or radiotherapy in the last 2 to 4 weeks.I haven't had signs of infection in the last 2 weeks.I have not had a severe infection in the last 4 weeks.I have cancer that has spread to the lining of my brain and spinal cord.My organs and bone marrow are working well.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.My Type 2 diabetes is not well-managed.You have had a bone marrow or solid organ transplant from another person.I have cSCC or MCC that has spread or returned despite treatment.I haven't taken any immune-weakening drugs in the last 2 weeks.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.I haven't had certain immune treatments in the last 6 weeks, except for anti-PD-L1/anti-PD-1 which was 3 weeks ago.I have tried and not responded to cancer treatment involving immune system boosters.You currently have active hepatitis B, which can be detected through a specific blood test.I do not have an active brain tumor or untreated brain metastases.People with HIV can participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Checkpoint Inhibitor-Naive cSCC, MCC Pts
- Group 2: Checkpoint Inhibitor-Relapsed/Refractory cSCC MCC Melanoma Pts
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available in the clinical trial for participants?
"Affirmative. The information hosted on clinicaltrials.gov shows that this medical trial, which was initially listed in December of 2019, is currently enrolling patients from 9 distinct sites and needs 84 volunteers overall."
Answered by AI
What number of medical centers are administering this clinical experiment in the region?
"Nine sites are participating in this clinical trial, such as Northwestern University in Chicago, Providence Portland Medical Center in Portland, and Dana Farber Cancer Institute located in Boston."
Answered by AI
What have medical practitioners primarily employed NT-I7 to address?
"NT-I7 is an accepted treatment for small cell lung cancer (SCLC) and can also help with malignant neoplasms, non-small cell lung carcinoma, or postoperative conditions."
Answered by AI
What is the cap for participants in this experiment?
"To meet the requirements of this medical investigation, 84 patients that align with the strict inclusion criteria must sign up. These participants can choose to engage in this trial from multiple sites such as Northwestern University in Chicago, Illinois and Providence Portland Medical Center in Portland, Oregon."
Answered by AI
Does this clinical trial represent a novel approach to treatment?
"Currently, there are 360 live research studies concerning NT-I7 in 1645 cities and 74 nations. In 2008, Hoffmann-La Roche initiated the initial clinical trial for this drug approval process with 720 participants; since then, 80 trials have been completed."
Answered by AI
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