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NCT03738228 · ClinicalTrials.gov registry record · Phase 1

Atezolizumab Before and/or With Chemoradiotherapy in Immune System Activation in Patients With Node Positive Stage IB2, II, IIIB, or IVA Cervical Cancer

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
40
Enrollment target

NCT03738228: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT03738228 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03738228, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target

Study Summary

This phase I trial studies how well atezolizumab before and/or with standard of care chemoradiotherapy works in immune system activation in patients with stage IB2, II, IIIB, or IVA cervical cancer that has spread to the lymph nodes. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab before and/or with chemoradiotherapy may lower the chance of tumors growing or spreading.

Primary Outcome

The immune response is measured by total T cell receptor beta (TCRB) clonal expansion in peripheral blood at day 21 from baseline using Adaptive Biotechnologies' immunoSEQ platform from Day -21 to Day 21 for group 1 (i.e., Arm A), and from Day 0 to Day 21 for group 2 (i.e., Arm B). The higher number of total TCR clonal expansion indicates better immune response.

Interventions

  • DRUG Atezolizumab
  • DRUG Cisplatin
  • RADIATION Brachytherapy
  • RADIATION Radiation Therapy

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2019-01-07
Est. Completion 2025-09-12
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT03738228 record still lists

NCT03738228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).

The record links to 0 conditions, and to 4 interventions - of which Atezolizumab is the first listed.

NCT03738228 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03738228 about?

NCT03738228 is a clinical study titled "Atezolizumab Before and/or With Chemoradiotherapy in Immune System Activation in Patients With Node Positive Stage IB2, II, IIIB, or IVA Cervical Cancer". This phase I trial studies how well atezolizumab before and/or with standard of care chemoradiotherapy works in immune system activation in patients with stage IB2, II, IIIB, or IVA cervical cancer that has spread to the lymph nodes. Immunotherapy with monoclonal antibodies, such as atezolizumab, ma...

What is the current status of trial NCT03738228?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2019-01-07. Estimated completion is 2025-09-12.

What interventions are being tested in trial NCT03738228?

The interventions under investigation include: Atezolizumab (DRUG), Cisplatin (DRUG), Brachytherapy (RADIATION), Radiation Therapy (RADIATION).

Who is sponsoring clinical trial NCT03738228?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03738228's enrollment target sits among peer trials

40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03738228, the US trial registry maintained by the National Library of Medicine. NCT03738228 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.