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Checkpoint Inhibitor

NT-I7 for Esophageal Cancer

Phase 1
Waitlist Available
Research Sponsored by NeoImmuneTech
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment combining NT-I7 with nivolumab to see if it is safe and effective in treating gastric or gastro-esophageal junction (GEJ) or esophageal adenocarcinoma (EAC). The study will first assess safety in escalating doses to find the maximum tolerated dose (MTD) or the recommended Phase 2 dose (RP2D). If the treatment is well tolerated, the study will then continue in Phase 2 to preliminary assess the antitumor activity and long-term survival of the treatment combination.

Eligible Conditions
  • Esophageal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose escalation: Number of participants who experience one or more common terminology criteria for adverse events (CTCAE) grade ≥ 3 adverse events
Dose escalation: Number of participants who experience one or more common terminology criteria for adverse events (CTCAE) grade ≥ 3 dose limiting toxicities (DLTs)
Dose escalation: Number of participants who experience one or more dose limiting toxicities (DLTs)
+2 more
Secondary outcome measures
Disease control rate (DCR)
Duration of response (DoR)
Number of participants with anti-drug antibodies (ADA) to NT-I7
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2: NT-I7 and NivolumabExperimental Treatment2 Interventions
NT-I7 will be administered on Day 1 of alternate 4 weeks cycles (Cycle 1, 3, 5 etc.) (Q8W) at the recommended phase 2 dose (RP2D) identified during Dose escalation phase. Nivolumab will be administered on Day 1 of every 4 week cycle (Q4W).
Group II: Dose escalationExperimental Treatment2 Interventions
NT-I7 will be administered on Day 1 of alternate 4 weeks cycles (Cycle 1, 3, 5 etc.) (Q8W). Dosage will increase until the maximum tolerated dose (MTD) and/or the recommended phase 2 (RP2D) dose is reached. Nivolumab will be administered on Day 1 of every 4 week cycle (Q4W).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

NeoImmuneTechLead Sponsor
10 Previous Clinical Trials
497 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,640 Previous Clinical Trials
4,129,454 Total Patients Enrolled

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 for participants in this trial?

"As suggested by the data found on clinicaltrials.gov, this trial is actively recruiting participants. The listing was first published on January 21st 2021 and has since been revised once more as of September 27th 2022."

Answered by AI

How widely distributed is the trial taking place in North America?

"Currently, this medical trial is operating at 4 sites located in Louisville, Fort Worth and Houston as well as other cities. To reduce the need for travel during participation, it is recommended to choose a location closest to your residence."

Answered by AI

Is there any prior research regarding NT-I7?

"Currently, there are 728 clinical studies underway that examine the effectiveness of NT-I7. 82 trials have been deemed Phase 3 and are being conducted at 40292 locations across the world with a concentration in Basel, BE."

Answered by AI

To what extent is participation in this experiment widespread?

"Affirmative. Clinicaltrials.gov documents corroborate that this trial, which was originally announced on January 21st 2021, is actively enrolling patients. Approximately 68 individuals must be recruited from four different medical institutions."

Answered by AI

What clinical scenarios is NT-I7 usually prescribed for?

"NT-I7 is conventionally used to treat cancerous tumors. It has shown promise in the treatment of difficult cancers such as melanoma, squamous cell carcinoma and metastatic esophageal adenocarcinoma."

Answered by AI

How hazardous are the effects of NT-I7 for participants?

"Due to the lack of efficacy data, NT-I7 was assigned a score of 2 on our safety scale. However, there is clinical evidence that it maintains a certain level of safety when used in Phase 2 trials."

Answered by AI

Is this an untested or pioneering experiment?

"Since 2012, NT-I7 has been the subject of numerous studies. The inaugural trial was sponsored by Ono Pharmaceutical Co. Ltd and incorporated 659 participants. This data set gained phase 1 & 2 drug approval, leading to an additional 728 active trials in 2354 cities across 49 nations presently."

Answered by AI
~2 spots leftby Apr 2025