 |
Diseases |  |
Trials |
|
Trials |  |
News |  |
- | MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Journal: MEDI0457 Plus Durvalumab in HPV-associated HNSCC-Response. (Pubmed Central) - Jul 18, 2023
No abstract available
- | MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Journal: MEDI0457 Plus Durvalumab in HPV-associated HNSCC-Letter. (Pubmed Central) - Jul 18, 2023
No abstract available No abstract available
- || MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
P2 data, Journal, Metastases: Phase II Trial of MEDI0457 and Durvalumab for Patients With Recurrent/Metastatic Human Papillomavirus-Associated Cancers. (Pubmed Central) - Apr 27, 2023
The combination of MEDI0457 and durvalumab demonstrated acceptable safety and tolerability in patients with advanced HPV-16/18 cancers. The low ORR among patients with cervical cancer led to study discontinuation despite a clinically meaningful disease control rate.
- |||| MEDI0457 / AstraZeneca
Clinical, Metastases: HPV-16/18 DNA vaccine MEDI0457 is safe and efficacious in patients with recurrent/metastatic head and neck squamous cell carcinoma. Efficacy endpoint was not reached but Aggarwal et al showed early and durable clinical responses. https://t.co/e4AgVPEasP @CharuAggarwalMD @agasco (Twitter) - Jan 6, 2023
- MEDI0457 / AstraZeneca, Avastin (bevacizumab) / Roche
Survival benefit to immunotherapy according to site of organ involvement in metastatic anal cancer. (On Demand | Level 1, West Hall; Poster Board No. A7) - Dec 13, 2022 - Abstract #ASCOGI2023ASCO_GI_676;
These data provide historical context in estimating median PFS necessary for future trial design in patients with metastatic anal cancer. Lymph node-only distribution of distant metastatic disease was predictive for improved survival with immunotherapy.
- | MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Journal, PD(L)-1 Biomarker, IO biomarker: Safety and Efficacy of MEDI0457 Plus Durvalumab in Patients With Human Papillomavirus-associated Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma. (Pubmed Central) - Dec 2, 2022
MEDI0457 plus durvalumab was well tolerated. While the primary efficacy endpoint was not reached, clinical benefit was encouraging.
- | MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Enrollment closed, Trial primary completion date, Metastases: DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers (clinicaltrials.gov) - Feb 14, 2022
P2, N=77, Active, not recruiting, Sponsor: M.D. Anderson Cancer Center
While the primary efficacy endpoint was not reached, clinical benefit was encouraging. Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2021 --> Dec 2022
- || MEDI0457 / AstraZeneca, Papitrol (tirvalimogene teraplasmid) / Genexine, National OncoVenture, bizalimogene ralaplasmid (VGX-3100) / Inovio
Review, Journal: The Efficacy of Therapeutic DNA Vaccines Expressing the Human Papillomavirus E6 and E7 Oncoproteins for Treatment of Cervical Cancer: Systematic Review. (Pubmed Central) - Jan 26, 2022
Five different DNA therapeutic vaccines (GX-188E, VGX-3100, pNGVL4a-CRT/E7(detox), pNGVL4a-Sig/E7(detox)/HSP70, MEDI0457) were well-tolerated and clinically effective. Clinical implementation of DNA therapeutic vaccines into treatment regimen as a sole approach or in combination with conservative treatment holds great potential for effective cancer treatment.
- MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
[VIRTUAL] Phase II trial of MEDI0457 and durvalumab for patients with recurrent/metastatic HPV-associated cancers. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2652;
P2
Despite a clinically meaningful DCR, the low ORR among pts with cervical cancer led to study discontinuation for futility . Correlative studies are ongoing to characterize pts with prolonged disease control with study treatment.
- || MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Trial completion, Metastases: Safety and Efficacy of MEDI0457 and Durvalumab in Participants With Human Papilloma Virus (HPV) Associated Recurrent/Metastatic Head and Neck Cancer (clinicaltrials.gov) - Apr 27, 2021
P1b/2a, N=35, Completed, Sponsor: MedImmune LLC
Correlative studies are ongoing to characterize pts with prolonged disease control with study treatment. Active, not recruiting --> Completed
- | MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date: Therapy for High-Risk HPV 16-Positive Oropharynx Cancer Patients (clinicaltrials.gov) - Apr 22, 2021
P2, N=0, Withdrawn, Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Active, not recruiting --> Completed N=66 --> 0 | Trial completion date: Sep 2027 --> Mar 2021 | Recruiting --> Withdrawn | Trial primary completion date: Sep 2024 --> Mar 2021
- || MEDI0457 / AstraZeneca
Clinical, P1 data, Journal: A Phase I trial assessing the safety and tolerability of a therapeutic DNA vaccination against HPV16 and HPV18 E6/E7 oncogenes after chemoradiation for cervical cancer. (Pubmed Central) - Feb 16, 2021
N=66 --> 0 | Trial completion date: Sep 2027 --> Mar 2021 | Recruiting --> Withdrawn | Trial primary completion date: Sep 2024 --> Mar 2021 Adjuvant MEDI0457 is safe and well-tolerated after chemoradiation for locally advanced and/or recurrent cervical cancers supporting further investigation into combining tumor-specific vaccines with radiotherapy.
- | MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Trial completion date, Trial primary completion date, Metastases: DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers (clinicaltrials.gov) - Dec 2, 2020
P2, N=77, Recruiting, Sponsor: M.D. Anderson Cancer Center
Adjuvant MEDI0457 is safe and well-tolerated after chemoradiation for locally advanced and/or recurrent cervical cancers supporting further investigation into combining tumor-specific vaccines with radiotherapy. Trial completion date: Jan 2020 --> Dec 2022 | Trial primary completion date: Jan 2020 --> Dec 2021
- ||| MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Very insightful presentation. Could you please tell more about the future plan for MEDI0457 durva combo in HPV+ SCCHN or Cervical? . Any pivotal trial initiation like Biontech ? (Twitter) - Sep 20, 2020
- ||||| MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Clinical: Safety and efficacy of MEDI0457, a DNA immunotherapeutic vaccine expressing HPV 16/18 E6/E7 proteins and IL-12 plus durvalumab in pts w HPV+ r/m HNSCC. ORR=22%. Surprisingly modest? @CharuAggarwalMD https://t.co/glGWWgVKOt (Twitter) - Sep 20, 2020
- ||||| MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Clinical: @myESMO Safety and efficacy of MEDI0457 plus durvalumab in patients (pts) with human papillomavirus-associated recurrent/metastatic head and neck squamous cell carcinoma (HPV+ R/M HNSCC) present by @CharuAggarwalMD 👏🏻 #ESMO20 👆🏻 @OncoAlert @PatelOncology @gary_lyman @GlopesMd (Twitter) - Sep 18, 2020
- MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
[VIRTUAL] Safety and efficacy of MEDI0457 plus durvalumab in patients (pts) with human papillomavirus-associated recurrent/metastatic head and neck squamous cell carcinoma (HPV+ R/M HNSCC) (On-Demand) - Jul 24, 2020 - Abstract #ESMO2020ESMO_1431;
P1b/2a
Funding: AstraZeneca. Clinical trial identification: NCT03162224.
- | MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Trial completion date, Trial primary completion date, Metastases: Safety and Efficacy of MEDI0457 and Durvalumab in Participants With Human Papilloma Virus (HPV) Associated Recurrent/Metastatic Head and Neck Cancer (clinicaltrials.gov) - May 5, 2020
P1b/2a, N=35, Active, not recruiting, Sponsor: MedImmune LLC
Clinical trial identification: NCT03162224. Trial completion date: Aug 2020 --> Mar 2021 | Trial primary completion date: Aug 2020 --> Mar 2021
- | MEDI0457 / AstraZeneca, MEDI-547 / AstraZeneca
Journal: Immunotherapy targeting HPV 16/18 generates potent immune responses in HPV-Associated Head and Neck Cancer. (Pubmed Central) - Feb 29, 2020
These data demonstrate that MEDI0457 can generate durable HPV16/18 antigen-specific peripheral and tumor immune responses. This approach may be used as a complementary strategy to PD-1/PD-L1 inhibition in HPV-associated HNSCCa to improve therapeutic outcomes.
- ||| MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Enrollment open, PD(L)-1 Biomarker: Therapy for High-Risk HPV 16-Positive Oropharynx Cancer Patients (clinicaltrials.gov) - Dec 3, 2019
P2, N=66, Recruiting, Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
This approach may be used as a complementary strategy to PD-1/PD-L1 inhibition in HPV-associated HNSCCa to improve therapeutic outcomes. Not yet recruiting --> Recruiting
- ||| MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Enrollment change, Metastases: Safety and Efficacy of MEDI0457 and Durvalumab in Participants With Human Papilloma Virus (HPV) Associated Recurrent/Metastatic Head and Neck Cancer (clinicaltrials.gov) - Nov 15, 2019
P1b/2a, N=35, Active, not recruiting, Sponsor: MedImmune LLC
Not yet recruiting --> Recruiting N=50 --> 35
- | MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Enrollment closed, Metastases: Safety and Efficacy of MEDI0457 and Durvalumab in Participants With Human Papilloma Virus (HPV) Associated Recurrent/Metastatic Head and Neck Cancer (clinicaltrials.gov) - Aug 1, 2019
P1b/2a, N=50, Active, not recruiting, Sponsor: MedImmune LLC
N=50 --> 35 Recruiting --> Active, not recruiting
- |||| MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
New P2 trial, PD(L)-1 Biomarker: Therapy for High-Risk HPV 16-Positive Oropharynx Cancer Patients (clinicaltrials.gov) - Jun 27, 2019
P2, N=66, Not yet recruiting, Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- | MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Enrollment open, Metastases: DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers (clinicaltrials.gov) - Nov 15, 2018
P2, N=77, Recruiting, Sponsor: M.D. Anderson Cancer Center
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Trial completion date, Metastases: DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers (clinicaltrials.gov) - Oct 5, 2018
P2, N=77, Not yet recruiting, Sponsor: M.D. Anderson Cancer Center
Not yet recruiting --> Recruiting Trial completion date: Jan 2021 --> Jan 2020
- || MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Trial initiation date, Metastases: DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers (clinicaltrials.gov) - Jul 16, 2018
P2, N=77, Not yet recruiting, Sponsor: M.D. Anderson Cancer Center
Trial completion date: Jan 2021 --> Jan 2020 Initiation date: Jun 2018 --> Sep 2018
- | MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Trial completion date, Trial primary completion date, Metastases: Safety and Efficacy of MEDI0457 and Durvalumab in Participants With Human Papilloma Virus (HPV) Associated Recurrent/Metastatic Head and Neck Cancer (clinicaltrials.gov) - Jun 12, 2018
P1b/2a, N=40, Recruiting, Sponsor: MedImmune LLC
Initiation date: Jun 2018 --> Sep 2018 Trial completion date: Mar 2020 --> Aug 2020 | Trial primary completion date: Mar 2020 --> Aug 2020
- ||| MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Trial initiation date, Metastases: DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers (clinicaltrials.gov) - Apr 12, 2018
P2, N=77, Not yet recruiting, Sponsor: M.D. Anderson Cancer Center
Trial completion date: Mar 2020 --> Aug 2020 | Trial primary completion date: Mar 2020 --> Aug 2020 Initiation date: Mar 2018 --> Jun 2018
- | MEDI0457 / AstraZeneca
Trial completion, Trial completion date: Study of HPV Specific Immunotherapy in Participants With HPV Associated Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - Mar 7, 2018
P1/2, N=22, Completed, Sponsor: Inovio Pharmaceuticals
Initiation date: Mar 2018 --> Jun 2018 Active, not recruiting --> Completed | Trial completion date: Oct 2017 --> Nov 2017
- MEDI0457 / AstraZeneca
Trial completion, Trial completion date, Trial primary completion date: A Study of INO-3112 DNA Vaccine With Electroporation in Participants With Cervical Cancer (clinicaltrials.gov) - Mar 1, 2018
P1/2, N=10, Completed, Sponsor: Inovio Pharmaceuticals
Active, not recruiting --> Completed | Trial completion date: Oct 2017 --> Nov 2017 Active, not recruiting --> Completed | Trial completion date: Mar 2018 --> Sep 2017 | Trial primary completion date: Sep 2017 --> Sep 2017
- ||||| MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
New P2 trial, Metastases: DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers (clinicaltrials.gov) - Feb 20, 2018
P2, N=77, Not yet recruiting, Sponsor: M.D. Anderson Cancer Center
- | MEDI0457 / AstraZeneca, Imfinzi (durvalumab) / AstraZeneca
Enrollment open, Metastases: Safety and Efficacy of MEDI0457 and Durvalumab in Participants With Human Papilloma Virus (HPV) Associated Recurrent/Metastatic Head and Neck Cancer (clinicaltrials.gov) - Sep 5, 2017
P1b/2a, N=40, Recruiting, Sponsor: MedImmune LLC
Active, not recruiting --> Completed | Trial completion date: Mar 2018 --> Sep 2017 | Trial primary completion date: Sep 2017 --> Sep 2017 Not yet recruiting --> Recruiting
- MEDI0457 / AstraZeneca
Enrollment closed, Enrollment change, Trial primary completion date: A Study of INO-3112 DNA Vaccine With Electroporation in Participants With Cervical Cancer (clinicaltrials.gov) - Aug 30, 2016
P1/2, N=10, Active, not recruiting, Sponsor: Inovio Pharmaceuticals
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | N=30 --> 10 | Trial primary completion date: Apr 2019 --> Sep 2017
- | MEDI0457 / AstraZeneca
Enrollment closed, Trial primary completion date: Study of HPV Specific Immunotherapy in Participants With HPV Associated Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - Jun 10, 2016
P1/2, N=22, Active, not recruiting, Sponsor: Inovio Pharmaceuticals
Recruiting --> Active, not recruiting | N=30 --> 10 | Trial primary completion date: Apr 2019 --> Sep 2017 Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2017 --> Dec 2016
- MEDI0457 / AstraZeneca
Enrollment change, Trial withdrawal, Combination therapy, Metastases: A Phase II Clinical Trial of Chemo-radiotherapy in Combination With INO-3112 in Patients With Locally Advanced Cervical Cancer (clinicaltrials.gov) - May 13, 2016
P2, N=0, Withdrawn, Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2017 --> Dec 2016 N=126 --> 0 | Not yet recruiting --> Withdrawn
- ||| MEDI0457 / AstraZeneca
Trial initiation date, Trial primary completion date, Combination therapy, Metastases: A Phase II Clinical Trial of Chemo-radiotherapy in Combination With INO-3112 in Patients With Locally Advanced Cervical Cancer (clinicaltrials.gov) - Jan 15, 2016
P2, N=126, Not yet recruiting, Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
N=126 --> 0 | Not yet recruiting --> Withdrawn Initiation date: Dec 2015 --> May 2016 | Trial primary completion date: Dec 2018 --> May 2019
- | MEDI0457 / AstraZeneca
Enrollment change, Trial primary completion date: Study of HPV Specific Immunotherapy in Participants With HPV Associated Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - Oct 22, 2015
P1/2, N=25, Recruiting, Sponsor: Inovio Pharmaceuticals
Initiation date: Dec 2015 --> May 2016 | Trial primary completion date: Dec 2018 --> May 2019 N=20 --> 25 | Trial primary completion date: Jun 2017 --> Dec 2017
- | MEDI0457 / AstraZeneca
Enrollment change, Trial primary completion date: A Study of INO-3112 DNA Vaccine With Electroporation in Participants With Cervical Cancer (clinicaltrials.gov) - Aug 25, 2015
P1/2, N=30, Recruiting, Sponsor: Inovio Pharmaceuticals
N=20 --> 25 | Trial primary completion date: Jun 2017 --> Dec 2017 N=20 --> 30 | Trial primary completion date: Apr 2016 --> Apr 2019
- ||||| MEDI0457 / AstraZeneca
New P2 trial, Combination therapy, Metastases: A Phase II Clinical Trial of Chemo-radiotherapy in Combination With INO-3112 in Patients With Locally Advanced Cervical Cancer (clinicaltrials.gov) - Jul 17, 2015
P2, N=126, Not yet recruiting, Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
- | MEDI0457 / AstraZeneca
New P1/2 trial: A Study of INO-3112 DNA Vaccine With Electroporation in Participants With Cervical Cancer (clinicaltrials.gov) - Jun 26, 2014
P1/2, N=20, Recruiting, Sponsor: Inovio Pharmaceuticals
- | MEDI0457 / AstraZeneca
Enrollment open, New P1/2 trial: A Study of INO-3112 DNA Vaccine With Electroporation in Participants With Cervical Cancer (clinicaltrials.gov) - Jun 26, 2014
P1/2, N=20, Recruiting, Sponsor: Inovio Pharmaceuticals
N=20 --> 30 | Trial primary completion date: Apr 2016 --> Apr 2019 Not yet recruiting --> Recruiting
- MEDI0457 / AstraZeneca
Phase classification: Study of HPV Specific Immunotherapy in Participants With HPV Associated Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - Jun 19, 2014
P1/2, N=20, Recruiting, Sponsor: Inovio Pharmaceuticals
Not yet recruiting --> Recruiting Phase classification: P1 --> P1/2
- | MEDI0457 / AstraZeneca
New P1/2 trial: Study of HPV Specific Immunotherapy in Participants With HPV Associated Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - Jun 19, 2014
P1/2, N=20, Recruiting, Sponsor: Inovio Pharmaceuticals
- | MEDI0457 / AstraZeneca
Enrollment open, Phase classification: Study of HPV Specific Immunotherapy in Participants With HPV Associated Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - Jun 19, 2014
P1/2, N=20, Recruiting, Sponsor: Inovio Pharmaceuticals
Phase classification: P1 --> P1/2 Not yet recruiting --> Recruiting | Phase classification: P1 --> P1/2
- | MEDI0457 / AstraZeneca
New P1 trial, New P1/2 trial: Study of HPV Specific Immunotherapy in Participants With HPV Associated Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - Jun 13, 2014
P1, N=20, Not yet recruiting, Sponsor: Inovio Pharmaceuticals