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1 Disease |  |
67 Trials |
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67 Trials |  |
1555 News |  |
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- REGN4018 / Regeneron, Sanofi, Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Phase I/II study of REGN4018, a Mucin-16 x cluster of differentiation 3 bispecific antibody, as monotherapy or in combination with cemiplimab in patients with recurrent ovarian cancer () - Jan 29, 2021 - Abstract #SGO2021SGO_702;
- || ubamatamab (REGN4018) / Regeneron, Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion date, Trial primary completion date, Combination therapy: Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers (clinicaltrials.gov) - Jan 29, 2021
P1/2, N=392, Recruiting, Sponsor: Regeneron Pharmaceuticals
Trial completion date: Mar 2023 --> Jan 2024 | Trial primary completion date: May 2022 --> Mar 2023
- |||||| Libtayo (cemiplimab) / Sanofi, Regeneron
P3 data, IO biomarker: #WCLC20 In this phase III trial, cemiplimab was superior to chemotherapy in the PDL1 50%+ group but as this analysis shows, PDL1 expression is a continuous variable and higher expression (90%) have the best results. #LCSM (Twitter) - Jan 28, 2021
- |||||| Libtayo (cemiplimab) / Sanofi, Regeneron
#WCLC20 Report of EMPOWER-Lung-1 with the PD1 inhibitor cemiplimab versus chemotherapy in driver-negative NSCLC. Here, analysis by PDL1 levels delivered by @CkapSaadettin #LCSM @IASLC @OncoAlert (Twitter) - Jan 28, 2021
- | Libtayo (cemiplimab-rwlc) / Regeneron, SAR439459 / Sanofi
New P1 trial, IO biomarker, Metastases: SAR439459 and Cemiplimab for the Treatment of Advanced or Unresectable Solid Tumors, Strategic Alliance, TACTIC TRIAL (clinicaltrials.gov) - Jan 27, 2021
P1b, N=40, Not yet recruiting, Sponsor: M.D. Anderson Cancer Center
- || Sarclisa (isatuximab-irfc) / Sanofi
Trial completion date, Trial primary completion date, Combination therapy, Metastases: Isatuximab in Combination With REGN2810 (Cemiplimab) in Patients With Advanced Malignancies (clinicaltrials.gov) - Jan 27, 2021
P1/2, N=134, Active, not recruiting, Sponsor: Sanofi
Trial completion date: Mar 2023 --> Jan 2024 | Trial primary completion date: May 2022 --> Mar 2023 Trial completion date: Jun 2021 --> Mar 2021 | Trial primary completion date: Jun 2021 --> Mar 2021
- | Voyager-V1 / Vyriad
Enrollment change, Trial completion date, Trial primary completion date: VSV-hIFNbeta-NIS in Treating Patients With Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma (clinicaltrials.gov) - Jan 25, 2021
P1, N=65, Recruiting, Sponsor: Mayo Clinic
Trial completion date: Jun 2021 --> Mar 2021 | Trial primary completion date: Jun 2021 --> Mar 2021 N=24 --> 65 | Trial completion date: Jan 2021 --> Dec 2021 | Trial primary completion date: Jan 2021 --> Dec 2021
- || Libtayo (cemiplimab-rwlc) / Regeneron, Erbitux (cetuximab) / Eli Lilly, EMD Serono
New P1 trial, Metastases: A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer (clinicaltrials.gov) - Jan 25, 2021
P1, N=10, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
- | Opdivo (nivolumab) / Ono Pharma, BMS
Retrospective data, Journal, Real-World Evidence: Programmed cell death protein 1 inhibitors in advanced cutaneous squamous cell carcinoma: real-world data of a retrospective, multicenter study. (Pubmed Central) - Jan 23, 2021
PD-1 inhibitors fulfill the need for an efficient systemic therapy for advanced cSCC and should be the new standard of care. With high RRs and durable disease control, neoadjuvant and adjuvant regimens should be evaluated.
- |||| ubamatamab (REGN4018) / Regeneron, Libtayo (cemiplimab-rwlc) / Regeneron, REGN5668 / Regeneron
Enrollment open, Combination therapy: R5668-ONC-1938: A Trial to Find Out How Safe REGN5668 is and How Well it Works When Given With Either Cemiplimab or REGN4018 (clinicaltrials.gov) - Jan 22, 2021
P1/2, N=290, Recruiting, Sponsor: Regeneron Pharmaceuticals
With high RRs and durable disease control, neoadjuvant and adjuvant regimens should be evaluated. Not yet recruiting --> Recruiting
- || SAR439459 / Sanofi
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Jan 20, 2021
P1, N=350, Recruiting, Sponsor: Sanofi
Not yet recruiting --> Recruiting Trial completion date: May 2022 --> Sep 2022 | Trial primary completion date: Nov 2021 --> Feb 2022
- | Pexa-Vec (pexastimogene devacirepvec) / SillaJen, Transgene
Phase classification, Combination therapy, Metastases: JX594-REN026: A Study of Recombinant Vaccinia Virus in Combination With Cemiplimab for Renal Cell Carcinoma (clinicaltrials.gov) - Jan 19, 2021
P1b/2a, N=117, Recruiting, Sponsor: SillaJen, Inc.
Trial completion date: May 2022 --> Sep 2022 | Trial primary completion date: Nov 2021 --> Feb 2022 Phase classification: P1b --> P1b/2a
- | Libtayo (cemiplimab) / Sanofi, Regeneron
Journal: RF-Cemiplimab: First Drug Approved for the Treatment of Metastatic or Unresectable Cutaneous Squamous Cell Carcinoma. (Pubmed Central) - Jan 15, 2021
Phase classification: P1b --> P1b/2a No abstract available
- | Libtayo (cemiplimab) / Regeneron
Enrollment change, Trial withdrawal: Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Classical Hodgkin Lymphoma (clinicaltrials.gov) - Jan 14, 2021
P2, N=0, Withdrawn, Sponsor: Regeneron Pharmaceuticals
No abstract available N=100 --> 0 | Not yet recruiting --> Withdrawn
- ||| BNT112 / BioNTech
Enrollment change, Combination therapy, Monotherapy: PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy) (clinicaltrials.gov) - Jan 14, 2021
P1/2, N=130, Recruiting, Sponsor: BioNTech SE
N=100 --> 0 | Not yet recruiting --> Withdrawn N=80 --> 130
- || Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
New P1/2 trial, PD(L)-1 Biomarker, IO biomarker, Metastases: LAG3 PET Imaging in Advanced Solid Tumors (clinicaltrials.gov) - Jan 12, 2021
P1/2, N=38, Not yet recruiting, Sponsor: University Medical Center Groningen
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] A phase I/II study of REGN5678 (Anti-PSMAxCD28, a costimulatory bispecific antibody) with cemiplimab (anti–PD-1) in patients with metastatic castration-resistant prostate cancer. () - Jan 8, 2021 - Abstract #ASCOGU2021ASCO_GU_692;
P1/2
At selected sites, prostate-specific membrane antigen PET/CT scans are performed at baseline and select time points on study. This study is currently open to enrollment.
- || BNT111 / BioNTech
Trial initiation date: Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma (clinicaltrials.gov) - Jan 6, 2021
P2, N=120, Not yet recruiting, Sponsor: BioNTech SE
This study is currently open to enrollment. Initiation date: Nov 2020 --> Mar 2021
- || Libtayo (cemiplimab) / Sanofi, Regeneron
Clinical, P1 data, Journal, Combination therapy: First-In-Human Study of Cemiplimab Alone or In Combination with Radiotherapy and/or Low Dose Cyclophosphamide in Patients with Advanced Malignancies. (Pubmed Central) - Jan 6, 2021
Addition of hfRT and/or CPA did not appear to increase grade ≥3 irAEs. Cemiplimab exhibited encouraging antitumor activity and durable responses.
- || Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal, Checkpoint inhibition: Emerging Therapies in Pheochromocytoma and Paraganglioma: Immune Checkpoint Inhibitors in the Starting Blocks. (Pubmed Central) - Jan 3, 2021
Besides, the newly detected predictors of response will (hopefully) be of great helps in selecting the subset of patients that might benefit the most from this class of drugs. Finally, new trials are in the starting blocks, and they are expected to shed in the next future new light on a therapy, which is considered a milestone in oncology.
- || Libtayo (cemiplimab) / Sanofi, Regeneron
Review, Journal: Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma. (Pubmed Central) - Dec 31, 2020
Overall, cemiplimab has a durable, clinically significant effect and an acceptable tolerability and safety profile. As the first approved treatment for this indication, cemiplimab represents a welcome therapeutic advance for patients with advanced CSCC.
- Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Evaluating the recurrence of immune-mediated toxicities in cancer patients after rechallenge with a checkpoint inhibitor () - Dec 26, 2020 - Abstract #ASHP2020ASHP_4553;
Data from patients that have been rechallenged on an ICI after experiencing an immune-mediated adverse event will be reviewed and used to evaluate the incidence of immune-mediated toxicity recurrence and whether or not the toxicity occurred in the same organ system as the initial toxicity. This information will also be used to describe corticosteroid dosing and duration following immune-mediated toxicities and evaluate the drug and patient characteristics that may predispose patients to developing immune-mediated toxicities.
- Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Identifying rare toxicities of immune checkpoint inhibitors in adults with cancer () - Dec 26, 2020 - Abstract #ASHP2020ASHP_4024;
The primary endpoint is to identify rare toxicities of immune checkpoint inhibitors that may be underreported in the literature. Secondary endpoints include the incidence of immune-mediated adverse events and appropriate side effect management per National Comprehensive Cancer Network (NCCN) guidelines.
- Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Evaluation of the management of immune related adverse events due to immune checkpoint inhibitor treatment in a regional cancer center and community hospital () - Dec 26, 2020 - Abstract #ASHP2020ASHP_2090;
Treatment strategies of irAEs will be evaluated for appropriateness and patient response. After collection and assessment of the data, this study will be utilized to develop and implement a supportive care plan to help providers manage irAEs.
- || Odomzo (sonidegib) / Sun Pharma, Libtayo (cemiplimab-rwlc) / Regeneron
New P2 trial, Combination therapy, Metastases: Anti-PD1-antibody and Pulsed HHI for Advanced BCC (clinicaltrials.gov) - Dec 22, 2020
P2, N=20, Not yet recruiting, Sponsor: Reinhard Dummer
- |||| Libtayo (cemiplimab-rwlc) / Regeneron, REGN7075 / Regeneron
Enrollment open, Combination therapy, Metastases: A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers (clinicaltrials.gov) - Dec 21, 2020
P1/2, N=312, Recruiting, Sponsor: Regeneron Pharmaceuticals
After collection and assessment of the data, this study will be utilized to develop and implement a supportive care plan to help providers manage irAEs. Not yet recruiting --> Recruiting
- ||| Hiltonol (poly-ICLC) / Oncovir
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: In Situ, Autologous Therapeutic Vaccination Against Solid Cancers With Intratumoral Hiltonol (clinicaltrials.gov) - Dec 17, 2020
P2, N=26, Completed, Sponsor: Oncovir, Inc.
Not yet recruiting --> Recruiting Recruiting --> Completed | N=100 --> 26 | Trial completion date: Dec 2021 --> Aug 2020 | Trial primary completion date: Jun 2021 --> Aug 2020
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Clinical Benefits of First-Line (1L) Cemiplimab Monotherapy by PD-L1 Expression Levels in Patients With Advanced NSCLC (Scientific Program Auditorium) - Dec 17, 2020 - Abstract #IASLCWCLC2020IASLC_WCLC_1673;
P3
Conclusion Overall, the benefit (OS, PFS, and ORR) with cemiplimab was superior to chemotherapy, and incrementally associated with PD-L1 expression levels. Thus, baseline PD-L1 expression levels may be used to identify patients with advanced NSCLC who are most likely to derive greatest benefit from 1L cemiplimab monotherapy.
- || Hiltonol (poly-ICLC) / Oncovir
Enrollment closed: Poly-ICLC (Hiltonol) and Anti-PD1 or Anti-PD-L1 (clinicaltrials.gov) - Dec 17, 2020
P1/2, N=60, Active, not recruiting, Sponsor: Oncovir, Inc.
Thus, baseline PD-L1 expression levels may be used to identify patients with advanced NSCLC who are most likely to derive greatest benefit from 1L cemiplimab monotherapy. Recruiting --> Active, not recruiting
- | Trial completion date, Trial primary completion date, Metastases: Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors (clinicaltrials.gov) - Dec 17, 2020
P3, N=578, Recruiting, Sponsor: Antoinette J Wozniak
Recruiting --> Active, not recruiting Trial completion date: Oct 2021 --> Oct 2025 | Trial primary completion date: Oct 2021 --> Oct 2025
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Cemiplimab and locally advanced or metastatic cutaneous squamous cell carcinomas: first real-life data. () - Dec 15, 2020 - Abstract #JDP2020JDP_512;
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Real-life tolerance of cemiplimab: retrospective single-center study () - Dec 15, 2020 - Abstract #JDP2020JDP_95;
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Development of trichilemmal carcinoma during immunotherapy with cemiplimab () - Dec 15, 2020 - Abstract #JDP2020JDP_94;
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Cemiplimab-induced cytokine release syndrome: first case () - Dec 15, 2020 - Abstract #JDP2020JDP_83;
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Real-life efficacy of cemiplimab in the treatment of advanced cutaneous squamous cell carcinoma () - Dec 15, 2020 - Abstract #JDP2020JDP_77;
- Libtayo (cemiplimab) / Sanofi, Regeneron, motixafortide (BL-8040) / BioLineRx, Abraxane (albumin-bound paclitaxel) / BMS, Otsuka
[VIRTUAL] Chemo4MetPanc: A phase II study with combination chemotherapy (gemcitabine and nab-paclitaxel), chemokine (C-X-C) motif receptor 4 inhibitor (motixafortide), and immune checkpoint blockade (cemiplimab) in metastatic treatment naïve pancreas adenocarcinoma (PDAC). () - Dec 9, 2020 - Abstract #ASCOGI2021ASCO_GI_453;
P2
Correlative aims include analyses of pre- and on-treatment biopsies with quantitative multiplex immunofluorescence, RNA-sequencing, and generation of patient derived organoids for association with clinical benefit and to determine mechanisms of action/resistance. An interim analysis will be performed at the conclusion of the stage I portion of the study.
- Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Does the intravesical administration of checkpoint inhibitors deserve consideration in non-muscle invasive bladder cancer? () - Dec 3, 2020 - Abstract #EMUC2020EMUC_140;
P1
Conclusions The checkpoint inhibitors represent an important development in the urothelial cancer and they deserve to be considered for intravesical administration. The NMI-BC might benefit from both the past experience and the new evidences in immunotherapy.
- ||||| Libtayo (cemiplimab) / Sanofi, Regeneron
#BRIDGE20 |Dirk Schadendorf: important data for #cemiplimab in CSCC and BCC @SamirNKhleif @PAscierto @JeromeGalon @BernardAFox @jasonlukemd @KunleOdunsiMD @3PSolution #immunotherapy #oncology #cancer #Congress (Twitter) - Dec 3, 2020
- |||||| Libtayo (cemiplimab) / Sanofi, Regeneron
#BRIDGE20 |Dirk Schadendorf: non-melanoma skin #Cancer updates of new developments at ASCO and ESMO 2020 @SamirNKhleif @PAscierto @JeromeGalon @BernardAFox @jasonlukemd @KunleOdunsiMD @3PSolution #cemiplimab #immunotherapy #oncology #Congress (Twitter) - Dec 3, 2020
- Libtayo (cemiplimab-rwlc) / Regeneron, Aphexda (motixafortide) / BioLineRx, Gloria Pharma
Trial initiation date, Checkpoint inhibition, Checkpoint block, Metastases: Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma (clinicaltrials.gov) - Dec 1, 2020
P2, N=10, Recruiting, Sponsor: Gulam Manji
The NMI-BC might benefit from both the past experience and the new evidences in immunotherapy. Initiation date: Oct 2020 --> Aug 2021
- |||| Libtayo (cemiplimab-rwlc) / Regeneron
New P2 trial, Metastases: Cemiplimab and ISA101b Vaccine in Adult Participants With Recurrent/Metastatic Human Papillomavirus (HPV)16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy (clinicaltrials.gov) - Nov 26, 2020
P2, N=103, Not yet recruiting, Sponsor: Regeneron Pharmaceuticals
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Demographics, Prior Therapies, and Reasons for Cemiplimab Treatment: Prospective CemiplimAb-rwlc Survivorship and Epidemiology (C.A.S.E.) Study in Patients with Advanced Cutaneous Squamous Cell Carcinoma () - Nov 25, 2020 - Abstract #FCDC2020FCDC_273;
Initiation date: Oct 2020 --> Aug 2021 Abstract not available.
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Phase 2 Study of Cemiplimab in Patients with Advanced Cutaneous Squamous Cell Carcinoma (CSCC): Longer Follow-Up () - Nov 25, 2020 - Abstract #FCDC2020FCDC_272;
Abstract not available. Abstract not available.
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Health-Related Quality of Life (HRQL) in Patients with Advanced Cutaneous Squamous Cell Carcinoma (CSCC) Treated with Cemiplimab: Post Hoc Exploratory Analysis of a Phase 2 Clinical Trial () - Nov 25, 2020 - Abstract #FCDC2020FCDC_270;
Abstract not available. Abstract not available.
- || pertuzumab zuvotolimod (SBT6050) / ARS Pharma
Enrollment change, Combination therapy, Metastases: A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors (clinicaltrials.gov) - Nov 19, 2020
P1, N=294, Recruiting, Sponsor: Silverback Therapeutics
Abstract not available. N=210 --> 294
- | Akalux (cetuximab sarotalocan) / Rakuten Medical
Phase classification, Combination therapy, Metastases: An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors (clinicaltrials.gov) - Nov 18, 2020
P1/2, N=74, Recruiting, Sponsor: Rakuten Medical, Inc.
N=210 --> 294 Phase classification: P1b/2 --> P1/2
- | Libtayo (cemiplimab-rwlc) / Regeneron
New P2 trial, Tumor mutational burden, PD(L)-1 Biomarker: NEO-CESQ: Neoadjuvant Plus Adjuvant Treatment With Cemiplimab in Cutaneaous Squamous Cell Carcinoma (clinicaltrials.gov) - Nov 17, 2020
P2, N=25, Not yet recruiting, Sponsor: Fondazione Melanoma Onlus
- || Sarclisa (isatuximab-irfc) / Sanofi
Trial completion date, Trial primary completion date, Combination therapy: A Study of Isatuximab-based Therapy in Participants With Lymphoma (clinicaltrials.gov) - Nov 17, 2020
P1/2, N=130, Active, not recruiting, Sponsor: Sanofi
Phase classification: P1b/2 --> P1/2 Trial completion date: Nov 2023 --> Dec 2022 | Trial primary completion date: Nov 2023 --> Dec 2022
- || rocakinogene sifuplasmid (INO-9012) / Inovio, INO-5401 / Inovio
Trial completion date, Trial primary completion date, Combination therapy: INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM) (clinicaltrials.gov) - Nov 16, 2020
P1/2, N=52, Active, not recruiting, Sponsor: Inovio Pharmaceuticals
Trial completion date: Nov 2023 --> Dec 2022 | Trial primary completion date: Nov 2023 --> Dec 2022 Trial completion date: Jan 2021 --> Jun 2021 | Trial primary completion date: Jan 2021 --> Jun 2021
- ||||| Libtayo (cemiplimab-rwlc) / Regeneron, REGN7075 / Regeneron
New P1/2 trial, Combination therapy, Metastases: A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers (clinicaltrials.gov) - Nov 11, 2020
P1/2, N=312, Not yet recruiting, Sponsor: Regeneron Pharmaceuticals