Clinical Studies

Clinical Trials

Several clinical trials of ISA Pharmaceuticals´ lead compound ISA101(b) are currently ongoing in HPV16-positive cancer indications, mostly in patients suffering from cervical cancer and head & neck cancer.

  • Recruitment goals of the company-sponsored CervISA trial have been met. In preparation of the Phase 2 trial design, additional patients were included to enlarge the patient numbers in the preferred dose range and to assess the effects of a new formulation. Initial results have been presented at ASCO-SITC, a manuscript is in preparation. The clinical results achieved thus far with ISA101 have been promising and, together with its collaborator Regeneron, ISA Pharmaceuticals will investigate the impact of adding checkpoint blockers to the study treatment regimens in patients with cervical cancer and head-and-neck cancer.
  • At MD Anderson Cancer Center, the team of Prof. B. Glisson conducted a clinical trial in the US in collaboration with Bristol Meyers Squibb and ISA Pharmaceuticals in incurable HPV16-positive cancer patients. In this study, patients were treated with a combination of ISA101 and Nivolumab. Initial results have been presented at ESMO, a manuscript is in preparation.
  • Another trial at the MD Anderson Cancer Center under supervision of Prof. B. Glisson has started recently. It is being conducted in collaboration with Pfizer and ISA Pharmaceuticals. In this study, incurable HPV16-positive oropharyngeal cancer patients will be treated with a combination of ISA101b and Utomilumab, a 41BB agonist. The study is still recruiting patients.
  • The safety and immunogenicity of ISA’s first SLP®-AMPLIVANT® conjugate ISA201 are currently validated in a study of patients with HPV16-positive tumors or premalignant lesions.

If you would like to receive more information about the ongoing trials, please send an e-mail to info@isa-pharma.com.

 

Ongoing Trials:

ISA101b+ Utomilumab

https://clinicaltrials.gov/ct2/show/NCT03258008

MDACC Study #2017-0145

ISA101b+Utomilumab

 

ISA101

CervISA (Phase I/II)

http://clinicaltrials.gov/show/NCT02128126

ISA101-CervISA_EN

 

ISA101+Nivolumab (Phase II)

MD Anderson Cancer Center in the United States of America

https://clinicaltrials.gov/ct2/show/NCT02426892

MDACC Study #2014-1047

ISA101-Nivolumab_EN_2

 

AIN (Phase I/II)

http://clinicaltrials.gov/ct2/show/NCT01923116

ISA101-VaccAIN_EN

 

ISA201

HESPECTA (Phase I/II)

Currently recruiting in the Netherlands at the Department of Clinical Oncology at Leiden University Medical Center:

http://clinicaltrials.gov/ct2/show/NCT02821494

ISA201-HESPECTA_EN

 

Completed Trials:

ISA101

ISA101_Completed Trials_EN