Primary To compare antitumor activity in ORR per Response Evaluation Criteria in Solid Tumor (RECIST) Guidelines version (v) 1.1 as assessed by blinded independent central review (BICR) in patients with incurable metastatic / recurrent HNSCC patients progressed on after anti-PD-1 and platinum containing therapy, treated with petosemtamab monotherapy vs investigator s choice monotherapy To compare OS in patients with incurable metastatic / recurrent HNSCC progressed on after anti-PD-1 and platinum-containing therapy, treated with petosemtamab monotherapy vs investigator s choice monotherapy Secondary To evaluate antitumor activity in ORR per RECIST v1.1 as assessed by investigator review To evaluate antitumor activity in DOR per RECIST v1.1 as assessed by BICR and investigator review To evaluate antitumor activity in TTR per RECIST v1.1 as assessed by BICR and investigator review To evaluate antitumor activity in PFS per RECIST v1.1 as assessed by BICR and by investigator review To evaluate antitumor activity in CBR per RECIST v1.1 as assessed by BICR and by investigator review Exploratory To explore the relevant tumor biomarkers in tumor and blood samples predictive of response or resistance to therapy

 

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 
 

Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:

Email: iutrials@iu.edu 

Phone: (317) 278-5632