- |||||||||| Campath (alemtuzumab) / Sanofi, Orencia (abatacept) / BMS
[VIRTUAL] Successful treatment of severe autoimmune enteropathy in a pediatric heart transplant recipient with abatacept and alemtuzumab () - Feb 3, 2021 - Abstract #AAAAI2021AAAAI_1030; We approached treatment similar to that of patients with allogeneic GVHD and initiated abatacept followed by a combination of abatacept and ruxolitinib, and, finally, a combination of abatacept and alemtuzumab. Following alemtuzumab she had a clinical response with cessation of gastrointestinal bleeding and entered remission on abatacept as a maintenance therapy. Conclusions We believe this is the first case of successful treatment of severe autoimmune enteropathy following a neonatal heart transplantation with the combination of abatacept and alemtuzumab.
- |||||||||| Signifor LAR (pasireotide) / Novartis, Sutent (sunitinib) / Pfizer
Journal, IO biomarker: Genomic profiles and current therapeutic agents in neuroendocrine neoplasms. (Pubmed Central) - Feb 3, 2021 Promising data regarding the use of everolimus and the novel SSA pasireotide for lung NENs are emerging, though additional studies are required to confirm these effects...Accumulating genomic information is expected to contribute to the development of novel therapies for other organ-derived NENs or poorly differentiated neuroendocrine carcinomas (NECs). Here, we provide an updated overview of the current knowledge regarding genomic profiles and representative agents for NENs and highlight the prospects for future investigations.
- |||||||||| everolimus / Generic mfg.
Trial completion date, Trial primary completion date, Metastases: Desiree: Dose EScalation Induction of EvERolimus (clinicaltrials.gov) - Feb 2, 2021 P2, N=156, Recruiting, The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021. Trial completion date: Mar 2021 --> Jul 2021 | Trial primary completion date: Dec 2020 --> Jun 2021
- |||||||||| Tamiflu (oseltamivir) / Gilead, Roche
Journal: COVID-19 management in heart transplanted recipients: registry of Almazov National Medical Research Centre. (Pubmed Central) - Feb 2, 2021 The outpatient treatment was started on the first day and included an antiviral therapy (oseltamivir), mucolytics (bromhexine), vitamin C, and anticoagulants...Hospitalized patients with moderately severe COVID-19 (n=3) were treated with oxygen inhalation through nasal cannula and prone position with a positive effect.Conclusion Remote counseling of patients after CT and consistency of the outpatient treatment with recommendations of managing transplant physicians provided timely diagnosis of IC, early administration of treatment, and the absence of COVID-19 complications. Reducing the regimen of immunosuppressive therapy (antiproliferative agents) for up to 14 days facilitated infection control and was not associated with acute rejection crisis and/or impairment of the transplant function.
- |||||||||| olvimulogene nanivacirepvec (GL-ONC1) / Genelux
Preclinical, Journal, Oncolytic Virus, IO biomarker: Oncolytic vaccinia virus GLV-1h68 exhibits profound antitumoral activities in cell lines originating from neuroendocrine neoplasms. (Pubmed Central) - Jan 30, 2021 In summary, the oncolytic vaccinia virus GLV-1 h68 was found to exhibit promising antitumoral activities, replication capacities and a potential for future combinatorial approaches in cell lines originating from neuroendocrine neoplasms. Based on these preliminary findings, virotherapeutic effects now have to be further evaluated in animal models for treatment of Neuroendocrine neoplasms (NENs).
- |||||||||| everolimus / Generic mfg., mycophenolate sodium / Generic mfg.
Trial completion, Post-transplantation: Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function (clinicaltrials.gov) - Jan 29, 2021 P3, N=329, Completed, Based on these preliminary findings, virotherapeutic effects now have to be further evaluated in animal models for treatment of Neuroendocrine neoplasms (NENs). Active, not recruiting --> Completed
- |||||||||| cisplatin / Generic mfg., everolimus / Generic mfg.
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: Cisplatinum and Everolimus in Patients With Metastatic or Unresectable NEC of Extrapulmonary Origin (clinicaltrials.gov) - Jan 29, 2021 P2, N=39, Active, not recruiting, Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021 Recruiting --> Active, not recruiting | Trial completion date: Jun 2021 --> Dec 2021 | Trial primary completion date: Jun 2020 --> Apr 2021
- |||||||||| everolimus / Generic mfg.
Trial completion date, Trial primary completion date, Combination therapy: Neoadj ph 2 AI Plus Everolimus in Postmenopausal Women w/ ER Pos/HER2 Neg, Low Risk Score (clinicaltrials.gov) - Jan 28, 2021 P2, N=17, Completed, Recruiting --> Active, not recruiting | Trial completion date: Jun 2021 --> Dec 2021 | Trial primary completion date: Jun 2020 --> Apr 2021 Trial completion date: Jun 2020 --> Nov 2020 | Trial primary completion date: Jun 2017 --> Nov 2020
- |||||||||| everolimus / Generic mfg.
Trial primary completion date, Metastases: Phase II Study of Everolimus Beyond Progression (clinicaltrials.gov) - Jan 26, 2021 P2, N=3, Active, not recruiting, Everolimus seems to have a poor diffusion in the pleural fluid. Trial primary completion date: Nov 2020 --> Nov 2021
- |||||||||| tamoxifen / Generic mfg., fulvestrant / Generic mfg.
Review, Journal: Management of ER positive metastatic breast cancer. (Pubmed Central) - Jan 26, 2021 The evolution of treatment for advanced disease from progestins, to the selective estrogen receptor modulator tamoxifen, and subsequently the aromatase inhibitors and the selective estrogen receptor degrader fulvestrant, has been accompanied by improved efficacy and decreased side effects...The first of these to receive FDA approval was the mTOR inhibitor everolimus (2012) [4], followed by the approval of 3 cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitors [palbociclib (2015) [5], ribociclib (2018) [6], and abemaciclib (2018) [7]], and more recently the PI3-kinase inhibitor alpelisib (2019) [8]...Like other incurable malignancies, the goal in advanced ER+ breast cancer is to prolong survival and maintain quality of life. Currently, we have more tools available to achieve this than ever before and we will review the efficacy and side effect data with these agents that are driving physician choices for individual patients.
- |||||||||| everolimus / Generic mfg.
Trial completion, Trial completion date, Combination therapy: Neoadj ph 2 AI Plus Everolimus in Postmenopausal Women w/ ER Pos/HER2 Neg, Low Risk Score (clinicaltrials.gov) - Jan 25, 2021 P2, N=17, Completed, Currently, we have more tools available to achieve this than ever before and we will review the efficacy and side effect data with these agents that are driving physician choices for individual patients. Suspended --> Completed | Trial completion date: Dec 2020 --> Jun 2020
- |||||||||| everolimus / Generic mfg.
Clinical, Journal: Complete recovery from COVID-19 of a kidney-pancreas transplant recipient: potential benefit from everolimus? (Pubmed Central) - Jan 21, 2021 Given the favourable outcome despite risk factors for severe COVID-19, we identify and review the potential mitigating roles of immunosuppression and mammalian target of rapamycin (mTOR) inhibitors in this disease. Further investigation is required to establish whether mTOR inhibitors could be used as therapeutic agents to treat COVID-19, or as alternative immunosuppression implemented early in the COVID-19 disease course.
- |||||||||| polyTregs / National Institute of Allergy and Infectious Diseases
Trial completion date, Trial primary completion date: TASK: Treg Therapy in Subclinical Inflammation in Kidney Transplantation (clinicaltrials.gov) - Jan 20, 2021 P1/2, N=30, Recruiting, Further investigation is required to establish whether mTOR inhibitors could be used as therapeutic agents to treat COVID-19, or as alternative immunosuppression implemented early in the COVID-19 disease course. Trial completion date: Oct 2021 --> Jun 2022 | Trial primary completion date: Oct 2021 --> Jun 2022
- |||||||||| everolimus / Generic mfg., sirolimus / Generic mfg.
Journal: Everolimus inhibits the progression of ductal carcinoma in situ to invasive breast cancer via downregulation of MMP9 expression. (Pubmed Central) - Jan 15, 2021 Mechanistically, everolimus treatment decreased the expression of MMP9 in the in vitro and in vivo models, and in breast tissues from DCIS patients treated with rapamycin for one week. Moreover, overexpression of MMP9 stimulated the invasion whereas knockdown of MMP9 inhibited the invasion of breast cancer cell-formed spheroids in vitro and DCIS in vivo Knockdown of MMP9 also nullified the invasion inhibition by everolimus in vitro and in vivo Targeting mTORC1 can inhibit DCIS progression to IDC via MMP9 and may be a potential strategy for DCIS or Early-Stage IDC therapy.
- |||||||||| everolimus / Generic mfg.
Trial completion date, Trial primary completion date: Everolimus for Children With Recurrent or Progressive Ependymoma (clinicaltrials.gov) - Jan 15, 2021 P2, N=11, Active, not recruiting, Moreover, overexpression of MMP9 stimulated the invasion whereas knockdown of MMP9 inhibited the invasion of breast cancer cell-formed spheroids in vitro and DCIS in vivo Knockdown of MMP9 also nullified the invasion inhibition by everolimus in vitro and in vivo Targeting mTORC1 can inhibit DCIS progression to IDC via MMP9 and may be a potential strategy for DCIS or Early-Stage IDC therapy. Trial completion date: Dec 2020 --> Jun 2021 | Trial primary completion date: Dec 2020 --> Jun 2021
- |||||||||| letrozole / Generic mfg., everolimus / Generic mfg.
Trial completion date, Combination therapy, Metastases: Bolero-4: Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer (clinicaltrials.gov) - Jan 14, 2021 P2, N=202, Active, not recruiting, Trial completion date: Dec 2020 --> Jun 2021 | Trial primary completion date: Dec 2020 --> Jun 2021 Trial completion date: Sep 2020 --> Jan 2021
- |||||||||| everolimus / Generic mfg.
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Liquid biopsy, Metastases, Biopsy: ESR1 Mutations in Asian ER+ Metastatic Breast Cancer on Hormonal Therapy-based Treatments (clinicaltrials.gov) - Jan 12, 2021 P=N/A, N=123, Active, not recruiting, Trial primary completion date: Dec 2020 --> Mar 2021 Recruiting --> Active, not recruiting | N=200 --> 123 | Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Jul 2020 --> Feb 2020
- |||||||||| everolimus / Generic mfg.
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: ENHVIE: Everolimus and Tacrolimus Combination for Regression of Left Ventricular Hypertrophy in Renal Transplants (clinicaltrials.gov) - Jan 8, 2021 P4, N=20, Completed, Recruiting --> Active, not recruiting | N=200 --> 123 | Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Jul 2020 --> Feb 2020 Recruiting --> Completed | N=40 --> 20 | Trial completion date: Nov 2018 --> May 2020 | Trial primary completion date: Nov 2018 --> May 2020
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