ATATcH Alternating Treatment Plans for Advanced Cancer
- Conditions
- Head and Neck CancerLung Cancer
- Interventions
- Registration Number
- NCT05358548
- Lead Sponsor
- Rutgers, The State University of New Jersey
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Head and Neck Squamous Cell Carcinoma 5Fluorouracil * A Cycles consist of Carboplatin/5-Fluorouracil/Pembrolizumab (up to six cycles standard) * B Cycles consist of Pembrolizumab alone Maintenance Cycles (Cycle 7 and beyond): Pembrolizumab alone, for up to two years since enrollment (standard) Head and Neck Squamous Cell Carcinoma Pembrolizumab * A Cycles consist of Carboplatin/5-Fluorouracil/Pembrolizumab (up to six cycles standard) * B Cycles consist of Pembrolizumab alone Maintenance Cycles (Cycle 7 and beyond): Pembrolizumab alone, for up to two years since enrollment (standard) Non-Squamous Lung Cancer Carboplatin * A Cycles consist of Carboplatin/Pemetrexed/Pembrolizumab (up to four cycles standard) * B Cycles consist of Pembrolizumab alone Maintenance Cycles (Cycle 5 and beyond): Pemetrexed in combination with Pembrolizumab; Alternatively, Pembrolizumab alone, for up to 2 years since enrollment (standard) Squamous Lung Cancer Pembrolizumab A Cycles consist of either: * Paclitaxel Based: Carboplatin/Paclitaxel/Pembrolizumab OR * nab-Paclitaxel Based: Carboplatin/nab Paclitaxel/Pembrolizumab These A Cycles will be given for up to four cycles (standard) B Cycles consist of Pembrolizumab alone Squamous Lung Cancer Paclitaxel A Cycles consist of either: * Paclitaxel Based: Carboplatin/Paclitaxel/Pembrolizumab OR * nab-Paclitaxel Based: Carboplatin/nab Paclitaxel/Pembrolizumab These A Cycles will be given for up to four cycles (standard) B Cycles consist of Pembrolizumab alone Squamous Lung Cancer Carboplatin A Cycles consist of either: * Paclitaxel Based: Carboplatin/Paclitaxel/Pembrolizumab OR * nab-Paclitaxel Based: Carboplatin/nab Paclitaxel/Pembrolizumab These A Cycles will be given for up to four cycles (standard) B Cycles consist of Pembrolizumab alone Non-Squamous Lung Cancer Pemetrexed * A Cycles consist of Carboplatin/Pemetrexed/Pembrolizumab (up to four cycles standard) * B Cycles consist of Pembrolizumab alone Maintenance Cycles (Cycle 5 and beyond): Pemetrexed in combination with Pembrolizumab; Alternatively, Pembrolizumab alone, for up to 2 years since enrollment (standard) Non-Squamous Lung Cancer Pembrolizumab * A Cycles consist of Carboplatin/Pemetrexed/Pembrolizumab (up to four cycles standard) * B Cycles consist of Pembrolizumab alone Maintenance Cycles (Cycle 5 and beyond): Pemetrexed in combination with Pembrolizumab; Alternatively, Pembrolizumab alone, for up to 2 years since enrollment (standard) Head and Neck Squamous Cell Carcinoma Carboplatin * A Cycles consist of Carboplatin/5-Fluorouracil/Pembrolizumab (up to six cycles standard) * B Cycles consist of Pembrolizumab alone Maintenance Cycles (Cycle 7 and beyond): Pembrolizumab alone, for up to two years since enrollment (standard)
- Primary Outcome Measures
Name Time Method Confidence Interval (CI) estimate of patients completing induction chemotherapy cycles up to 30 weeks 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 \[up to 30 weeks for patients with head and neck cancer\]).
- Secondary Outcome Measures
Name Time Method Progression Free Survival 36 months Overall response rates 4 week prior to initial treatment and at six week follow -up time point via response evaluation criteria in solid tumors (RECIST 1.1)
Safety as assessed by number of participants experiencing adverse events 36 months Number of participants experiencing adverse events grade three or higher, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE, v5.0)
Trial Locations
- Locations (11)
RWJBarnabas Health - Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
RWJBarnabas Health - Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
RWJBarnabas Health - Jersey City
🇺🇸Jersey City, New Jersey, United States
RWJ Barnabas Health - Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States
Cancer Institute of New Jersey at Hamilton
🇺🇸Hamilton, New Jersey, United States
Trinitas Hospital and Comprehensive Cancer Center
🇺🇸Elizabeth, New Jersey, United States
Robert Wood Johnson Somerset Hospital
🇺🇸Somerville, New Jersey, United States
RWJBarnabas Health - Saint Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
RWJBarnabas Health - Monmouth Medical Center Southern Campus
🇺🇸Lakewood, New Jersey, United States
RWJBarnabas Health - Community Medical Center
🇺🇸Toms River, New Jersey, United States