SPEARHEAD 2 Study in Subjects With Recurrent or Metastatic Head and Neck Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04408898|
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Genetic: ADP-A2M4 in combination with pembrolizumab.||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Pilot Study of ADP-A2M4 in Combination With Pembrolizumab in Subjects With Recurrent or Metastatic Head and Neck Cancer|
|Actual Study Start Date :||July 2, 2020|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||October 2036|
|Experimental: ADP-A2M4 T cells in combination with pembrolizumab||
Genetic: ADP-A2M4 in combination with pembrolizumab.
Single infusion of autologous genetically modified ADP-A2M4 Dose: 1.0 x109 to 10x109 transduced cells by a single intravenous infusion Repeat doses of pembrolizumab every 3 weeks. Dose: 200mg
- Efficacy: Overall Response Rate (ORR) [ Time Frame: 2.5 years ]ORR is defined as the proportion of complete responses or partial responses as assessed by RECIST v1.1
- Best overall response (BOR) [ Time Frame: 2.5 years ]BOR defined as the best response recorded from the date of T cell infusion until disease progression.
- Time to response (TTR) [ Time Frame: 2.5 years ]TTR defined as the duration between T cell infusion and the initial date of the confirmed response.
- Duration of response (DoR) [ Time Frame: 2.5 years ]DoR defined as the duration from the initial date of the confirmed response to the date of PD (or death).
- Duration of stable disease (DoSD) [ Time Frame: 2.5 years ]DoSD defined as the duration from the date of T cell infusion to the date of PD (or death).
- Progression- free survival (PFS) [ Time Frame: 2.5 years ]PFS defined as the interval between the date T cell infusion and the earliest date of disease progression based on RECIST v1.1 or death due to any cause.
- Overall survival (OS) [ Time Frame: 2.5 years ]OS defined the duration between T cell infusion and death due to any cause.
- To evaluate the safety and tolerability of ADP-A2M4 with pembrolizumab by determining incidence of Adverse events (AEs) including serious adverse events (SAEs) [ Time Frame: 2.5 years ]Determination of incidence, severity and duration of adverse events through assessment of adverse events including SAEs. Adverse events will be collected and graded as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
- To evaluate the safety and tolerability of ADP-A2M4 with pembrolizumab by determining the incidence, severity and duration of the AEs of special interest [ Time Frame: 2.5 years ]Adverse events of special interest will be listed along with duration and toxicity grade.
- To evaluate safety of ADP-A2M4 with pembrolizumab through measurement of Replication-competent Lentivirus in genetically engineered T-cells [ Time Frame: 15 years ]Evaluation of RCL using PCR-based assay in peripheral blood.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04408898
|Contact: Adaptimmune Patient Enquiriesfirstname.lastname@example.org|
|United States, California|
|University of California San Diego||Recruiting|
|San Diego, California, United States, 92093|
|Contact: Khushbu Singh 858-246-2604 email@example.com|
|Contact: Elizabeth Alpert (858) 822-1562 firstname.lastname@example.org|
|Principal Investigator: Ezra Cohen, MD|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Contact: Jeff Roesgen 913-945-8679 email@example.com|
|Contact: Richard Dugan-Starr, BA 913-574-0481 firstname.lastname@example.org|
|Principal Investigator: Prakash Neupane, MD|
|United States, Oregon|
|Providence Cancer Institute Franz Head and Neck Clinic||Recruiting|
|Portland, Oregon, United States, 97213|
|Contact: Katie Tripp 503-215-0449 Katie.Tripp@providence.org|
|Contact: George Morris 503-215-7503 George.Morris@providence.org|
|Principal Investigator: Rom Leidner, MD|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37212|
|Contact: Kathy Taylor 615-875-0060 Kathy.email@example.com|
|Contact: Jayashree Adarsh Jayashree.firstname.lastname@example.org|
|Principal Investigator: Michael Gibson, MD|