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13 Trials |
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- || sitravatinib (MGCD516) / BeiGene
P1 data, Journal: Sitravatinib in patients with solid tumors selected by molecular alterations: results from a Phase Ib study. (Pubmed Central) - Nov 15, 2024
P1
The study closed before the planned number of patients were enrolled in all cohorts. Sitravatinib had a manageable safety profile with modest signals of clinical activity in patients with molecularly selected solid tumors.Clinical trial registration: www.clinicaltrials.gov identifier is NCT02219711.
- | sitravatinib (MGCD516) / BeiGene, Rybrevant (amivantamab-vmjw) / J&J
Journal: Detailed characterization of combination treatment with MET inhibitor plus EGFR inhibitor in EGFR-mutant and MET-amplified non-small cell lung cancer. (Pubmed Central) - Nov 7, 2024
Pneumonitis was the main adverse effects leading to treatment discontinuation. Early discontinuation of METi negatively affected the survival outcomes.
- sitravatinib (MGCD516) / BeiGene, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Phase 1 Study of Sitravatinib Combined with Nivolumab and Ipilimumab in Patients with Advanced Clear Cell Renal Cell Carcinoma: Clinical Outcomes and Translational Correlatives (Commonwealth 4-5) - Nov 6, 2024 - Abstract #IKCS2024IKCS_123;
P1
The observed changes in gene expression and cellular states highlight potential biomarkers for resistance and may guide future strategies to enhance ICT effectiveness in ccRCC. ClinicalTrials.gov Identifier: NCT04518046
- Tevimbra (tislelizumab-jsgr) / BeiGene, sitravatinib (MGCD516) / BeiGene
Tislelizumab plus sitravatinib and nab-paclitaxel in patients with untreated locally recurrent or metastatic triple negative breast cancer (TNBC): updated efficacy and safety results. (Stars at Night 1-2) - Nov 1, 2024 - Abstract #SABCS2024SABCS_192;
- | Biomarker, Journal, PARP Biomarker: Screening of differential gene expression patterns through survival analysis for diagnosis, prognosis and therapies of clear cell renal cell carcinoma. (Pubmed Central) - Sep 30, 2024
Their ADME/T analysis and cross-validation with the independent receptors, also supported their potent against ccRCC. Therefore, these outputs might be useful inputs/resources to the wet-lab researchers and clinicians for considering an effective treatment strategy against ccRCC.
- ||| BGB-A445 / BeiGene
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy: A Study of BGB-A445 in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer (clinicaltrials.gov) - Sep 19, 2024
P2, N=35, Active, not recruiting, Sponsor: BeiGene
Therefore, these outputs might be useful inputs/resources to the wet-lab researchers and clinicians for considering an effective treatment strategy against ccRCC. Recruiting --> Active, not recruiting | N=100 --> 35 | Trial completion date: May 2026 --> Dec 2024 | Trial primary completion date: Jan 2026 --> Dec 2024
- || Tevimbra (tislelizumab-jsgr) / BeiGene, sitravatinib (MGCD516) / BeiGene
P1/2 data, Journal, Metastases: SAFFRON-104: a phase Ib/II study of sitravatinib alone or with tislelizumab in advanced hepatocellular carcinoma and gastric cancer/gastroesophageal junction cancer. (Pubmed Central) - Sep 5, 2024
P1/2
Recruiting --> Active, not recruiting | N=100 --> 35 | Trial completion date: May 2026 --> Dec 2024 | Trial primary completion date: Jan 2026 --> Dec 2024 Sitravatinib with/without tislelizumab was generally well tolerated and showed preliminary antitumor activity in patients with advanced HCC and GC/GEJC.
- Tevimbra (tislelizumab-jsgr) / BeiGene, sitravatinib (MGCD516) / BeiGene
SAFFRON-301: Tislelizumab Plus Sitravatinib in Advanced/Metastatic NSCLC Progressing on/after Chemotherapy and Anti-PD-(L)1 (20BC) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_869;
P3
The trial was terminated due to safety risks/unfavorable benefit-risk analysis. Conclusions : In patients with previously treated advanced/metastatic NSCLC, TIS+sitra showed similar efficacy to doc and was associated with a higher incidence of TEAEs.
- || sitravatinib (MGCD516) / BeiGene
Trial completion, Metastases: AAAQ8661: Sitravatinib in Advanced Liposarcoma and Other Soft Tissue Sarcomas (clinicaltrials.gov) - Jul 18, 2024
P2, N=29, Completed, Sponsor: Columbia University
Conclusions : In patients with previously treated advanced/metastatic NSCLC, TIS+sitra showed similar efficacy to doc and was associated with a higher incidence of TEAEs. Active, not recruiting --> Completed
- || sitravatinib (MGCD516) / BeiGene, Opdivo (nivolumab) / BMS
P2 data, Journal, Combination therapy, Metastases: A Phase 2 Study of Sitravatinib in Combination with Nivolumab in Patients with Advanced or Metastatic Urothelial Carcinoma. (Pubmed Central) - Jul 17, 2024
P2
Active, not recruiting --> Completed Sitravatinib plus nivolumab demonstrated a manageable safety profile but did not result in clinically meaningful ORRs in patients with advanced/metastatic UC in the eight cohorts studied.
- ||| sitravatinib (MGCD516) / BeiGene, Opdivo (nivolumab) / BMS
Trial completion date, Combination therapy, Checkpoint inhibition, Metastases: SAPPHIRE: Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - Jun 25, 2024
P3, N=577, Active, not recruiting, Sponsor: Mirati Therapeutics Inc.
Sitravatinib plus nivolumab demonstrated a manageable safety profile but did not result in clinically meaningful ORRs in patients with advanced/metastatic UC in the eight cohorts studied. Trial completion date: Apr 2024 --> Dec 2024
- | Tevimbra (tislelizumab-jsgr) / BeiGene, sitravatinib (MGCD516) / BeiGene
Phase classification, Combination therapy, Metastases: SAFFRON-103: A Phase 1b Study to Assess Sitravatinib in Combination With Tislelizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - Jun 16, 2024
P1, N=216, Completed, Sponsor: BeiGene
Trial completion date: Apr 2024 --> Dec 2024 Phase classification: P1b --> P1
- || sitravatinib (MGCD516) / BeiGene, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion, Enrollment change, Trial completion date, Combination therapy, Metastases: Study of Sitravatinib, Nivolumab and Ipilimumab in Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies (clinicaltrials.gov) - Jun 4, 2024
P1, N=22, Completed, Sponsor: Mirati Therapeutics Inc.
Phase classification: P1b --> P1 Active, not recruiting --> Completed | N=92 --> 22 | Trial completion date: Feb 2024 --> Jun 2023
- sitravatinib (MGCD516) / BeiGene
Trial termination, Metastases: H-43432: Sitravatinib in Metastatic Breast Cancer (clinicaltrials.gov) - May 15, 2024
P2, N=3, Terminated, Sponsor: Xiang Zhang
Active, not recruiting --> Completed | N=92 --> 22 | Trial completion date: Feb 2024 --> Jun 2023 Withdrawn --> Terminated; Terminated by sponsor due to lack of interest
- |||| Tevimbra (tislelizumab-jsgr) / BeiGene, Partruvix (pamiparib) / EMD Serono
Trial completion date, Trial primary completion date, Metastases: BGB-A317-290-LTE1: Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies (clinicaltrials.gov) - May 15, 2024
P3, N=300, Enrolling by invitation, Sponsor: BeiGene
Withdrawn --> Terminated; Terminated by sponsor due to lack of interest Trial completion date: Aug 2024 --> Dec 2026 | Trial primary completion date: Aug 2024 --> Dec 2026
- || Trial completion date, Trial primary completion date, IO biomarker: National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer (clinicaltrials.gov) - May 12, 2024
P2, N=423, Active, not recruiting, Sponsor: University of Birmingham
Trial completion date: Aug 2024 --> Dec 2026 | Trial primary completion date: Aug 2024 --> Dec 2026 Trial completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: Sep 2023 --> Sep 2024
- ||||| sitravatinib (MGCD516) / BeiGene
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases: Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study (clinicaltrials.gov) - May 8, 2024
P2/3, N=55, Active, not recruiting, Sponsor: Mirati Therapeutics Inc.
Trial completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: Sep 2023 --> Sep 2024 Enrolling by invitation --> Active, not recruiting | N=200 --> 55 | Trial completion date: Apr 2024 --> Apr 2025 | Trial primary completion date: Apr 2024 --> Apr 2025
- | sitravatinib (MGCD516) / BeiGene
Journal, Metastases: Concentration-QTc modeling of sitravatinib in patients with advanced solid malignancies. (Pubmed Central) - May 3, 2024
The upper bounds of the 90% CIs were below the regulatory threshold of concern of 10?ms. The results of the described C-QTc analysis, along with corroborating results from nonclinical safety pharmacology studies, indicate that sitravatinib has a low risk of QTc interval prolongation at the proposed therapeutic dose of 100?mg malate q.d.
- | sitravatinib (MGCD516) / BeiGene
Journal: Blockade of Discoidin Domain Receptor Signaling with Sitravatinib Reveals DDR2 as a Mediator of Neuroblastoma Pathogenesis and Metastasis. (Pubmed Central) - Apr 27, 2024
Analysis of single cell sequencing data demonstrated that DDR2 is restricted to mesenchymal-type tumor subpopulations and is enriched in Schwann Cell Precursor (SCP) subpopulations found in high-risk disease. These data define an unsuspected role for sitravatinib as a therapeutic agent in neuroblastoma and reveal a novel function for DDR2 as a driver of tumor growth and metastasis.
- Tevimbra (tislelizumab-jsgr) / BeiGene, sitravatinib (MGCD516) / BeiGene
Tislelizumab plus sitravatinib as adjuvant therapy for patients with hepatocellular carcinoma at high risk of recurrence after surgical resection: Preliminary analysis of a multi-center, non-randomized, open-label phase 2 study. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_5341;
P2
Further follow-up is needed to validate these findings with more mature data. Clinical trial information: NCT05407519.
- Tevimbra (tislelizumab-jsgr) / BeiGene, sitravatinib (MGCD516) / BeiGene
Phase II study of sitravatinib in combination with tislelizumab in patients with advanced biliary tract cancer who have failed to at least 1 prior systemic treatment. (E451) - Apr 24, 2024 - Abstract #ASCO2024ASCO_3951;
P2
Sitravatinib/tiselizumab combination as 2L therapy in patients with advanced BTC demonstrated meaningful efficacy and an acceptable safety profile. Especially, patient selection using HRD biomarker might be a promising strategy in this setting.
- sitravatinib (MGCD516) / BeiGene, Opdivo (nivolumab) / BMS
A phase II trial of sitravatinib plus nivolumab after progression on prior immune checkpoint inhibitor (ICI) in patients with metastatic clear cell renal cell carcinoma (ccRCC). (Hall A; Poster Bd #: 237) - Apr 24, 2024 - Abstract #ASCO2024ASCO_1708;
P2
In this small phase 2 trial with limited sample size due to early termination, sitravatinib plus nivolumab demonstrated a manageable safety profile and produced modest clinical benefit. The observed responses occurred in patients who did not receive prior treatment with cabozantinib or lenvatinib.
- ||||| Trial termination, Combination therapy, Metastases: MRTX-500: Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Non-Small Cell Lung Cancer (clinicaltrials.gov) - Apr 22, 2024
P2, N=161, Terminated, Sponsor: Mirati Therapeutics Inc.
The observed responses occurred in patients who did not receive prior treatment with cabozantinib or lenvatinib. Completed --> Terminated; This study was terminated as a result of Sponsor portfolio reprioritization.
- | Tevimbra (tislelizumab-jsgr) / BeiGene, sitravatinib (MGCD516) / BeiGene
Trial completion date, Trial primary completion date, Combination therapy, Metastases: BTC-BGB: Phase II Study of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Biliary Tract Cancer (clinicaltrials.gov) - Apr 19, 2024
P2, N=43, Active, not recruiting, Sponsor: Seoul National University Hospital
Completed --> Terminated; This study was terminated as a result of Sponsor portfolio reprioritization. Trial completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Jul 2023
- sitravatinib (MGCD516) / BeiGene
Trial withdrawal, Metastases: H-43432: Sitravatinib in Metastatic Breast Cancer (clinicaltrials.gov) - Mar 15, 2024
P2, N=0, Withdrawn, Sponsor: C. Kent Osborne, MD
Trial completion date: Jun 2024 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Jul 2023 Terminated --> Withdrawn
- ||| Tevimbra (tislelizumab-jsgr) / BeiGene, sitravatinib (MGCD516) / BeiGene
Enrollment closed, Enrollment change, Trial completion date, Combination therapy, Metastases: SITISVEAL: Sitravatinib and Tislelizumab in Patients With Metastatic Uveal Melanoma With Liver Metastases. (clinicaltrials.gov) - Mar 12, 2024
P2, N=16, Active, not recruiting, Sponsor: Grupo Espa
Terminated --> Withdrawn Recruiting --> Active, not recruiting | N=34 --> 16 | Trial completion date: Aug 2024 --> May 2024
- sitravatinib (MGCD516) / BeiGene
Lipid-based nanoparticle combination immunotherapy with sitravatinib for the systemic treatment of high-risk neuroblastoma (Section 3) - Mar 5, 2024 - Abstract #AACR2024AACR_6909;
Here, we have proposed and tested an immunotherapy with great promise for treating neuroblastoma. However, the impact of nanoparticle-based immunotherapy reaches far beyond neuroblastoma: it has the potential to be a platform for the development of immunotherapies specific to other highly metastatic cancer types.
- ||||| Tevimbra (tislelizumab) / BeiGene, sitravatinib (MGCD516) / BeiGene
Trial completion date, Trial termination, Trial primary completion date, Combination therapy, Metastases: Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - Mar 3, 2024
P2, N=96, Terminated, Sponsor: BeiGene
- ||||||||| Tevimbra (tislelizumab) / BeiGene, sitravatinib (MGCD516) / BeiGene
Trial termination, Combination therapy, Metastases: BGB-A317-Sitra-301: Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - Mar 2, 2024
P3, N=377, Terminated, Sponsor: BeiGene
However, the impact of nanoparticle-based immunotherapy reaches far beyond neuroblastoma: it has the potential to be a platform for the development of immunotherapies specific to other highly metastatic cancer types. Completed --> Terminated; Due to safety risks and unfavorable risk-benefit assessment results, the sponsor has decided to voluntarily terminate the study.
- sitravatinib (MGCD516) / BeiGene, Keytruda (pembrolizumab) / Merck (MSD)
Trial completion date, Trial termination, Trial primary completion date, Metastases: Sitravatinib Plus Pembrolizumab in Patients With Advanced Treatment-Na (clinicaltrials.gov) - Feb 15, 2024
P2, N=9, Terminated, Sponsor: Sarah Goldberg
Completed --> Terminated; Due to safety risks and unfavorable risk-benefit assessment results, the sponsor has decided to voluntarily terminate the study. Trial completion date: Feb 2025 --> Oct 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Feb 2025 --> Jun 2023; Sponsor decision based on data from other clinical trials
- || Tevimbra (tislelizumab) / BeiGene, sitravatinib (MGCD516) / BeiGene
P1 data, Clinical Trial,Phase I, Journal, Metastases: SAFFRON-103: a phase Ib study of sitravatinib plus tislelizumab in anti-PD-(L)1 refractory/resistant advanced melanoma. (Pubmed Central) - Feb 5, 2024
P1b
Sitravatinib plus tislelizumab had manageable safety/tolerability in patients with anti-PD-(L)1 refractory/resistant unresectable/advanced/metastatic melanoma, with promising antitumor activity. Clinical Trial Registration: NCT03666143 (ClinicalTrials.gov).
- | Tevimbra (tislelizumab-jsgr) / BeiGene, sitravatinib (MGCD516) / BeiGene
Enrollment change, Trial termination, Metastases: STELLAR: Tislelizumab Combined With Sitravatinib as Consolidation Treatment Following Concurrent Chemoradiation in Patients With Locally Advanced, Unresectable NSCLC (clinicaltrials.gov) - Jan 28, 2024
P2, N=5, Terminated, Sponsor: Fudan University
Clinical Trial Registration: NCT03666143 (ClinicalTrials.gov). N=36 --> 5 | Recruiting --> Terminated; The trial was terminated per sponsor recommendation
- ||||||| Tevimbra (tislelizumab) / BeiGene, sitravatinib (MGCD516) / BeiGene
Trial completion, Trial completion date, Trial primary completion date, Combination therapy, Metastases: BGB-A317-Sitra-301: Tislelizumab in Combination With Sitravatinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov) - Jan 26, 2024
P3, N=377, Completed, Sponsor: BeiGene
N=36 --> 5 | Recruiting --> Terminated; The trial was terminated per sponsor recommendation Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> Dec 2023 | Trial primary completion date: Jun 2024 --> Dec 2023
- ||| sitravatinib (MGCD516) / BeiGene, Opdivo (nivolumab) / Ono Pharma, BMS
P3 data, Journal, Metastases: SAPPHIRE: Phase III Study of Sitravatinib Plus Nivolumab Versus Docetaxel in Advanced Non-Squamous Non-Small Cell Lung Cancer. (Pubmed Central) - Jan 15, 2024
Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> Dec 2023 | Trial primary completion date: Jun 2024 --> Dec 2023 Although median OS was numerically longer with sitra
- sitravatinib (MGCD516) / BeiGene
Effect of sitravatinib combined with PD-1 blockade on cytotoxic T-cell infiltration by M2 to M1 tumor macrophage repolarization in esophageal adenocarcinoma. (Poster Bd # J6) - Dec 6, 2023 - Abstract #ASCOGI2024ASCO_GI_266;
All tumor bearing animals were randomized to a dose of 10mg/kg of sitravatinib (S) or vehicle control (VC) for three cycles, and PD-1 inhibitor, AUNP-12 (IO), was administered on day 12 of each 14 day cycle, at a dose of 3mg/kg. This study establishes a favorable combinational strategy using sitravatinib to overcome immunosuppression in the TME, providing strong rationale for future clinical strategies in the treatment of EAC.
- | sitravatinib (MGCD516) / Mirati
Journal, PD(L)-1 Biomarker, IO biomarker: Sitravatinib combined with PD1 blockade enhances cytotoxic T-Cell infiltration by M2 to M1 tumor macrophage repolarization in esophageal adenocarcinoma. (Pubmed Central) - Nov 29, 2023
Additionally, pre-treatment gene expression of TAM receptors and PD-L1 were significantly higher in major responders compared to the non-responders, in animals that received sitravatinib and AUNP-12 (P < 0.02), confirming that TAM suppression enhances the efficacy of PD-1 blockade. In conclusion, this study proposes a promising immunomodulatory strategy using a multi-gene TKI to overcome developed resistance to an ICI in EAC, establishing rationale for future clinical development.
- | Tevimbra (tislelizumab-jsgr) / BeiGene, sitravatinib (MGCD516) / BeiGene
Trial completion date, Trial primary completion date, Combination therapy, Metastases: BTC-BGB: Phase II Study of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Biliary Tract Cancer (clinicaltrials.gov) - Nov 27, 2023
P2, N=43, Active, not recruiting, Sponsor: Seoul National University Hospital
In conclusion, this study proposes a promising immunomodulatory strategy using a multi-gene TKI to overcome developed resistance to an ICI in EAC, establishing rationale for future clinical development. Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Jun 2023 --> Dec 2023
- | Tevimbra (tislelizumab-jsgr) / BeiGene, sitravatinib (MGCD516) / BeiGene
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: BGB-900-2001-IIT: A Phase II Study to Explore the Safety, Tolerability, and Preliminary Antitumor Activity of Sitravatinib Plus Tislelizumab or Combination With Nab-paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC) (clinicaltrials.gov) - Nov 18, 2023
P2, N=98, Active, not recruiting, Sponsor: Fudan University
Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Jun 2023 --> Dec 2023 Completed --> Active, not recruiting | Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Jun 2023 --> Jun 2024
- | Tevimbra (tislelizumab-jsgr) / BeiGene, sitravatinib (MGCD516) / BeiGene
Trial completion, Trial primary completion date, Metastases: BGB-900-2001-IIT: A Phase II Study to Explore the Safety, Tolerability, and Preliminary Antitumor Activity of Sitravatinib Plus Tislelizumab or Combination With Nab-paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC) (clinicaltrials.gov) - Nov 14, 2023
P2, N=98, Completed, Sponsor: Fudan University
Completed --> Active, not recruiting | Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Jun 2023 --> Jun 2024 Recruiting --> Completed | Trial primary completion date: Oct 2022 --> Jun 2023
- ||| BGB-A445 / BeiGene
Enrollment open, Combination therapy: A Study of BGB-A445 in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer (clinicaltrials.gov) - Nov 8, 2023
P2, N=100, Recruiting, Sponsor: BeiGene
Recruiting --> Completed | Trial primary completion date: Oct 2022 --> Jun 2023 Not yet recruiting --> Recruiting
- ||| Tevimbra (tislelizumab) / BeiGene, sitravatinib (MGCD516) / BeiGene
Enrollment open, Combination therapy, Metastases: Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - Nov 7, 2023
P2, N=100, Recruiting, Sponsor: BeiGene
Not yet recruiting --> Recruiting Active, not recruiting --> Recruiting
- Tevimbra (tislelizumab) / BeiGene, sitravatinib (MGCD516) / Mirati
Phase II study of sitravatinib plus tislelizumab with or without nab-paclitaxel in patients with locally recurrent or metastatic triple negative breast cancer (Hall 2-3) - Nov 4, 2023 - Abstract #SABCS2023SABCS_497;
In the first-line treatment of locally recurrent or metastatic TNBC, preliminary analysis of cohort C showed that sitravatinib combined with tislelizumab and nab-paclitaxel had promising anti-tumor activity with a high ORR, and the combination was generally well tolerated. In TNBC pts with less than three lines of therapy, the chemotherapy-free regimen with sitravatinib plus tislelizumab demonstrated promising PFS after a longer follow-up duration.
- |||| sitravatinib (MGCD516) / BeiGene, Opdivo (nivolumab) / BMS
Trial completion date, Trial primary completion date, Combination therapy, Checkpoint inhibition, Metastases: SAPPHIRE: Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - Oct 23, 2023
P3, N=532, Active, not recruiting, Sponsor: Mirati Therapeutics Inc.
In TNBC pts with less than three lines of therapy, the chemotherapy-free regimen with sitravatinib plus tislelizumab demonstrated promising PFS after a longer follow-up duration. Trial completion date: Jul 2023 --> Apr 2024 | Trial primary completion date: Sep 2022 --> Mar 2023
- || sitravatinib (MGCD516) / BeiGene, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date, Combination therapy, Metastases: Study of Sitravatinib, Nivolumab and Ipilimumab in Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies (clinicaltrials.gov) - Oct 23, 2023
P1, N=92, Active, not recruiting, Sponsor: Mirati Therapeutics Inc.
Trial completion date: Jul 2023 --> Apr 2024 | Trial primary completion date: Sep 2022 --> Mar 2023 Trial completion date: Jun 2023 --> Feb 2024 | Trial primary completion date: Mar 2023 --> Jun 2023
- || sitravatinib (MGCD516) / Mirati
Trial completion: A Study to Evaluate the Effect of Mild, Moderate, and Severe Hepatic Impairment on Pharmacokinetics of Sitravatinib (clinicaltrials.gov) - Oct 23, 2023
P1, N=30, Completed, Sponsor: Mirati Therapeutics Inc.
Trial completion date: Jun 2023 --> Feb 2024 | Trial primary completion date: Mar 2023 --> Jun 2023 Active, not recruiting --> Completed
- || sitravatinib (MGCD516) / BeiGene, Opdivo (nivolumab) / BMS
Trial completion, Trial completion date, Trial primary completion date, Metastases: PK Study to Assess Drug-drug Interaction and QTc Between Sitravatinib and a Cocktail of Substrates (clinicaltrials.gov) - Oct 23, 2023
P1, N=40, Completed, Sponsor: Mirati Therapeutics Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed | Trial completion date: Dec 2023 --> Dec 2022 | Trial primary completion date: Jun 2023 --> Dec 2022
- || Tevimbra (tislelizumab) / BeiGene, sitravatinib (MGCD516) / BeiGene
Enrollment closed, Combination therapy, Metastases: Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - Oct 23, 2023
P2, N=100, Active, not recruiting, Sponsor: BeiGene
Active, not recruiting --> Completed | Trial completion date: Dec 2023 --> Dec 2022 | Trial primary completion date: Jun 2023 --> Dec 2022 Recruiting --> Active, not recruiting
- || sitravatinib (MGCD516) / BeiGene, Opdivo (nivolumab) / BMS
Trial completion, Combination therapy, IO biomarker, Metastases: Neoadjuvant Sitravatinib in Combination With Nivolumab in Patients With Clear Cell Renal Cell Carcinoma (clinicaltrials.gov) - Oct 4, 2023
P2, N=25, Completed, Sponsor: Mirati Therapeutics Inc.
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- | Tevimbra (tislelizumab-jsgr) / BeiGene, sitravatinib (MGCD516) / BeiGene
Enrollment closed: BGB-900-2003-IIT: A Study to Investigate the Efficacy and Safety of Tislelizumab Combined With Sitravatinib as Maintenance Therapy for ES-SCLC (clinicaltrials.gov) - Sep 26, 2023
P2, N=21, Active, not recruiting, Sponsor: Zhejiang Cancer Hospital
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- |||| BGB-A445 / BeiGene
New P2 trial, Combination therapy: A Study of BGB-A445 in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer (clinicaltrials.gov) - Sep 8, 2023
P2, N=100, Not yet recruiting, Sponsor: BeiGene