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Recruiting PHASE2 INTERVENTIONAL NCT05358548

ATATcH Alternating Treatment Plans for Advanced Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The purpose of the research is to evaluate a new schedule of alternating cycles of induction chemoimmunotherapy (chemotherapy plus pembrolizumab) and immunotherapy (pembrolizumab) alone for the initial treatment of patients with advanced lung or head and neck cancers.

Detailed Description

This study is looking at the effect of alternating combination chemotherapy plus immunotherapy with immunotherapy alone during the induction phase (resulting in less frequent use of chemotherapy, once every six weeks instead of the usual every three weeks during induction) on the ability to fight your tumor. We expect that less frequent exposure to chemotherapy in this setting will control your cancer effectively while preserving your quality of life. The primary endpoint of this three-arm, parallel phase II study is the percentage of patients receiving one, two, three and four (up to six for patients with head and neck cancer) combination chemoimmunotherapy cycles. Along with, overall response rates at six weeks and the best response rate. Additionally, to record the safety and tolerability of therapy.

Interventions

Name: Paclitaxel
Type: DRUG
Description: Is a chemotherapy drug. Used to treat kinds of cancer, as determined by the doctor
Name: Pemetrexed
Type: DRUG
Description: Is a chemotherapy drug. Used to treat kinds of cancer, as determined by the doctor
Name: 5Fluorouracil
Type: DRUG
Description: Is a chemotherapy drug. Used to treat kinds of cancer, as determined by the doctor
Name: Carboplatin
Type: DRUG
Description: Is a chemotherapy drug. Used to treat kinds of cancer, as determined by the doctor
Name: Pembrolizumab
Type: DRUG
Description: It is a type of immunotherapy and works by helping your immune system to kill cancer cells

Primary Outcomes

Measure: Confidence Interval (CI) estimate of patients completing induction chemotherapy cycles
TimeFrame: up to 30 weeks
Description: The primary endpoint of this three-arm, parallel phase II study is the percentage of patients in each of the study arms receiving 1, 2, 3 and 4 (up to 6 cycles for head and neck cancer) induction combination chemoimmunotherapy (termed "A") cycles (reflecting timepoints of 0, six weeks, twelve weeks, and eighteen weeks on study, respectively \[up to 30 weeks for patients with head and neck cancer\]).

Trial Information

NCT ID

NCT05358548

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Rutgers, The State University of New Jersey

Last Updated

December 15, 2025