ca/rcr-rcn/clinical-trials last updated: December 18, 2017 by Jida El Hajjar any comments or changes: jida. I. gov, number NCT02089685. ∗. Presented at 2015 ASCO Annual Meeting; May 29-Jun 2, 2015; Chicago, IL. Therefore, several studies are investigating whether a lower dose or longer dosing intervals of ipilimumab in combination with pembrolizumab (such as in. 1. 150†. Phase, Phase 1/Phase 2. FINDINGS: Between Jan 13, 2015, and Sept 17, 2015, we enrolled and treated 153 patients. Pembrolizumab, ipilimumab, interferon alpha-2B. 102†. Seattle Cancer Care Alliance currently has over 200 clinical trials open for patients including Phase 1 Program trials. In the other study, it is being tested alone or in combination with pazopanib (NCT02014636). + ipilimumab dose finding. • KEYNOTE-029 (ClinicalTrials. Contact Investigators or Research Sites near you. By participating in a clinical trial, you will be helping researchers answer important questions that will further the development of new  29 Jan 2018 This combination is being further developed using flat dose pembrolizumab, 200mg Q3W, and ipilimumab, 50mg every 6 weeks or 100mg Q12W, with a maximum of four ipilimumab doses (NCT02089685). Nivolumab, anti-LAG3. NCT02212730. A Phase 1/2 Clinical  26 Jul 2017 One of them is testing pembrolizumabalone or in combination with pegylated interferon-α (NCT02089685). Atezolizumab was evaluated in a  Study ID: Merck MK-3475-029. (NCT02085070) and the activity and safety of combination therapy with pegylated interferon alpha (NCT02112032 and NCT02089685 [KEYNOTE-029]), dabrafenib and tra- metinib (KEYNOTE-022, NCT02130466), and ipilimumab. I and II. In part 1C, 2 more dosing  Experimental Design: The phase 1b KEYNOTE-029 study (ClinicalTrials. NCT02178722. Monoclonal antibodies are supposed to identify tumor cells by their  4 Dec 2017 ABSTRACT. Yes. STATUS: Recruiting (accepting new patients) (per ClinicalTrials. gov/NCT02089685)  9 Feb 2017 Two ongoing Phase II clinical trials are evaluating pembrolizumab with or without interferon while another is evaluating the PD-1 inhibitor with or without standard-of-care pazopanib in the metastatic RCC setting (NCT02089685, Memorial Sloan Kettering 14-074). Abstr 3013. Phase, phase 1/phase 2. Keynote-029; NCT02089685) or nivolumab  Clinicaltrials. 2 mg every three weeks in combination with ipilimumab 1 mg/kg every three weeks. ClinicalTrials. Sponsor: Merck  25 Sep 2017 - 2 minMichael Atkins, MD, from the Georgetown Lombardi Comprehensive Cancer Center 6 Oct 2017 To evaluate whether the combination of Keytruda and a reduced-dose of Yervoy could induce robust responses with less toxicity, an open-label Phase 1/2 clinical trial (KEYNOTE-029; NCT02089685) was undertaken. A “personalized neoantigen cancer vaccine” called NeoVax is evaluated in a  Yes. Therapy for cutaneous melanoma has advanced greatly through careful identification of therapeutic targets and the development of novel immunotherapeutic  2018年2月22日 这项Ⅰb期研究(NCT02089685)分为两组：一组为派姆单抗加上减量的伊匹单抗，一组为派姆单抗加上长效α-2b干扰素。如果≤6/18例患者出现一次剂量限制性毒性(DLT)，则认为派姆单抗2 mg/kg q3w联合伊匹单抗1mg/kg q3w是可耐受的。而派姆单抗2 mg/kg q3w联合干扰素组的目标DLT率是30%，每个剂量组最多 . Source: Cliniccaltrials. gov, NCT02089685. This study is being done to analyze the safety, tolerability, and efficacy of treatment for advanced melanoma (MEL) and renal cell carcinoma (RCC) using combination regimens of pembrolizumab + pegylated interferon alfa-2b (PegIFN-2b) and pembrolizumab + ipilimumab (IPI). Public title: Safety and Tolerability of Pembrolizumab (MK-3475) + Pegylated Interferon Alfa-2b and Pembrolizumab+ Ipilimumab in Participants With Advanced Melanoma  6 Jun 2016 Preliminary data from the phase 1 KEYNOTE-029 study (NCT02089685) suggested that standard-dose pembro + reduced-dose ipi was safe and provided robust antitumor activity. Pembrolizumab 2 mg/kg every 3 weeks (Q3W) plus 4 doses of ipilimumab 1 mg/kg Q3W was  Conditions, renal cell carcinoma, melanoma. Pembrolizumab + PEG-IFN-alpha-2b versus pembrolizumab + ipilimumab versus pembrolizumab (Keynote-029)d, I/II, 343, NCT02089685. Date of registration: 14/03/2014. Pembrolizumab 2 mg/kg Q3W plus 4 doses of ipilimumab 1 mg/kg Q3W was tolerable if ≤6/18 patients experienced a  ploring the potential to treat asymptomatic brain disease. • Ongoing phase I/II study of pembrolizumab + ipilimumab or pegylated interferon for patients with advanced or metastatic melanoma or renal cell carcinoma (RCC). Number of AE and SAE. Last updated: July 06, 2017. Merck & Co, Keytruda +peg-IFN, Keynote-029, 293, NCT02089685, Apr 2020. In addition to the therapies approved by Health Canada, patients may be able to access several other therapies through clinical trials. •. Phase: I/II. gov, NCT02089685) included independent pembrolizumab plus reduced-dose ipilimumab and pembrolizumab plus PEG-IFN cohorts. Combination tolerable based on DLT rate and AE profile1,2. Trial identifier, NCT02089685, 2013-004072-36, 3475-029  30 May 2017 Here, we present more mature data, including 1-y landmark PFS and OS estimates. Numbers of AE, determination. Clinical Study Identifier: NCT02089685. In part 1C, 2 more dosing regimens of this  Evaluate the use of time-to-growth modeling and simulation and correlate with clinical outcomes in patients with advanced melanoma or RCC treated with pembrolizumab alone or with PEG-IFN or ipilimumab. Promising early Phase I trials of  efficacy of Vemurafenib/PEG-interferon combination Recruiting; 12/2016 3 NCT02089685 Unresectable metastatic melanoma To analyze the safety, tolerability and efficacy of the combination of pembrolizumab + p-IFNα2b and Not recruiting; 01/2018 pembrolizumab + ipilimumab 4 NCT02379195 Unresectable metastatic  Pembrolizumab is being evaluated in two randomized phase 2 trials; in one (NCT02089685), pembrolizumab is being evaluated alone and in combination with pegylated IFNα; another study (NCT02014636) is evaluating pembrolizumab as monotherapy or in combination with pazopanib. Number of AE. MK-3475/pembrolizumab. Principle Investigator: Dr. 168†. Trial size, 293 participants. Updated March 15, 2018. Enrolment into this cohort is closed, but patients are still being monitored for safety and anti-tumour activity. (KEYNOTE-029, NCT02089685). METHODS. List of Clinical Trials. Patients. MEDI4736, MEDI0680. NCT02014636. Results Status, ongoing. Dose-limiting toxicities (DLT) evaluated in  18 Sep 2017 Background: Standard-dose pembro (2 mg/kg Q3W) + reduced-dose ipi (1 mg/kg Q3W × 4 doses) showed preliminary efficacy in patients (pts) with melanoma in part 1B of the phase 1/2 KEYNOTE-029 study (NCT02089685), but 42% of pts had treatment-related AEs (TRAEs). NCT01295827. Official Title: A Phase I/II Clinical Trial to Study the Safety and Tolerability of MK-3475 +  Part 1C (MEL) is added as the third part of the study with Amendment 3. Dose Expansion. Id, NCT02089685 [view on www. NCT02089685. NCT02318771. elhajjar@mail. NCT Number: NCT02089685. (EN) A Phase II Study of Pembrolizumab With Carboplatin/Paclitaxel in Patients With Metastatic Melanoma MK-3475-269. CR1730MK. 23 Nov 2015 agent, Study, Detail, Trial ID. mcgill. Status, Recruiting. (Part 1B). NCT01968109. 17 Oct 2017 NOTE-029 (NCT02089685), is evaluating the efficacy of pembrolizumab (another monoclonal antibody targeting PD-1) at. End date, June 2020. Atkins MA et al. Monoclonal antibodies (mAbs) that block the programmed death 1 (PD-1) or programmed death-ligand 1 (PD-L1) receptors are the most clinically advanced tumor immunotherapies. Combination with indoleamine-2,3-dioxygenase (IDO) inhibitor. While the start of this decade could be defined as the 'watershed' era in melanoma therapeutics, we  Secondary end points: ORR, DOR, PFS, OS. A randomized phase III study evaluating efficacy and safety of pembrolizumab in combination with axitinib  Ipilimumab is also being investigated in association with other drugs for the treatment of advanced RCC, as discussed previously, like nivolumab within the CheckMate 214 study or pembrolizumab within the Keynote-29 study [NCT02089685] [66]. •Advanced MEL. Girentuximab. A total of 153 patients with advanced melanoma and no brain metastasis, who had not  Overview of KEYNOTE-029 (NCT02089685). • Data presented here: pembrolizumab. No. Number with DLT and AE, PFS. Experimental design: The phase 1b KEYNOTE-029 study (ClinicalTrials. KEYNOTE-029. NCT01975831. IDO is an intracellular enzyme  Investigations into altered dose schedules of checkpoint inhibitor combinations are underway (NCT02714218, NCT02089685), and may help identify a more tolerable combination regimen without compromise of efficacy. MEDI4736, tremelimumab. The primary hypothesis is that these  Full entry on ClinicalTrials. Given the broad antitumor efficacy and novel mechanism of action, numerous combinatorial approaches  18 Dec 2017 https://www. 8 Jan 2018 Main ID: NCT02089685. Abstr 3009. NCT02210117. Merck/Novartis, Keytruda + Votrient, Keynote-18, 248, NCT02014636, Dec 2018. Pembrolizumab + bevacizumab, I/II, 61, NCT02348008. I/II. /pidilizumab. Research Study Number: 2017-0193. Long G et al ASCO  NCT01472081. Bristol-Myers Squibb, Opdivo + Yervoy, Checkmate-800, 100, NCT03029780, Feb 2018. A ''personalized neoanti- gen cancer vaccine” called NeoVax is evaluated in a combination with ipilimumab for the treatment of advanced RCC patients. Yervoy, Keynote-029, 56% ORR, 3/72 CRs and 37/72 PRs; 93% treatment-related AEs. gov identifier: NCT02089685) is an ongoing, multicenter,  14 Mar 2017 treatment has substantial toxicity (55% of patients with grade 3 or worse treatment-related adverse events). As of the Oct 17, 2016, cutoff date,  22 Jan 2018 Experimental Design: The phase Ib KEYNOTE-029 study (ClinicalTrials. Here, we present data from a larger population of patients (pts) treated with pembro + ipi in the KEYNOTE-029 expansion  10 Sep 2017 Standard-dose pembro (2 mg/kg Q3W) + reduced-dose ipi (1 mg/kg Q3W × 4 doses) showed preliminary efficacy in patients (pts) with melanoma in part 1B of the phase 1/2 KEYNOTE-029 study (NCT02089685), but 42% of pts had treatment-related AEs (TRAEs). Passive immunotherapy. Sponsor, Merck Sharp & Dohme Corp. gov Identifier: NCT02089685. NCT02133742. PD-1. 17 Jul 2017 This trial is registered with ClinicalTrials. Title, Safety and Tolerability of Pembrolizumab (MK-3475) + Pegylated Interferon Alfa-2b and Pembrolizumab+ Ipilimumab in Participants With Advanced Melanoma or Renal Cell Carcinoma (MK-3475-029/KEYNOTE-29). Prospective Registration: Yes. •≥0 prior therapies. Human IgG4 monoclonal Ab. NCT01354431. NCT02617849, CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL, Mélanome. Imlygic (T-Vec), Masterkey-265, 56% ORR, 2/16 CRs and 7/16 PRs. clinicaltrials. Title, A Phase 1/2 Clinical Trial to Study the Safety and Tolerability of MK-3475 + Pegylated Interferon Alfa-2b (PEG-IFN) and MK-3475 + Ipilimumab (IPI) in Subjects With Advanced Melanoma (MEL) and Renal Cell Carcinoma (RCC) (KEYNOTE 029). NCT02089685  22 Feb 2017 Phase II. Part 1C will evaluate safety and efficacy for different doses and dosing intervals for IPI in combination with pembrolizumab in participants with advanced MEL. 9. Presented at 2016 ASCO Annual Meeting; Jun 3-Jun 7, 2016; Chicago, IL. 9 Jan 2016 Nivolumab + BMS-986016 (anti–LAG-3), I, 198, NCT01968109. 20 While some questions remain unanswered, it is clear that combina- tion therapy has changed the  Keynote-29 study [NCT02089685] [66]. Human IgG1 monoclonal Ab. The phase 1b KEYNOTE-029 trial (ClinicalTrials. NCT02263508. gov]. NCT02231749. Primary sponsor: Merck Sharp & Dohme Corp. Targets, PD-1, CTLA-4. Pembrolizumab + lenvatinib (VEGFR TKI), I/II  18 Jul 2017 and reduced-dose nivolumab improved objective response (OR) and progression-free survival (PFS) in patients with advanced melanoma, but had increased toxicity. •ECOG PS 0 or 1. •No prior anti–CTLA-4,. Study Design. PD-1, or PD-L1. 343. Epacadostat, Keynote-037, 53% ORR, 3/19 CRs and 7/19 PRs. Pembrolizumab 2 mg/kg Q3W plus 4 doses of ipilimumab 1 mg/kg Q3W was tolerable if ≤6/18 patients experienced  NCT02089685, CHU DE QUEBEC – UNIVERSITE LAVAL L'HOTEL-DIEU DE QUEBEC ET CRCEO, Mélanome. gov Identifier: NCT02089685) enrolled 153 patients with advanced melanoma who were  NCT01668784. Methods: In the phase 1 KEYNOTE-029 expansion cohort (NCT02089685), pts with advanced melanoma, ECOG PS 0-1, no active brain metastases, and no prior immune checkpoint inhibitor therapy received pembro 2  Safety and Tolerability of Pembrolizumab (MK-3475) + Pegylated Interferon Alfa-2b and Pembrolizumab+ Ipilimumab in Participants With Advanced Melanoma or Renal Cell Carcinoma (MK-3475-029/KEYNOTE-29) - NCT02089685. Andrew Pecora. NCT01668784. Bristol-Myers Squibb, Opdivo + BMS-986016  6 Mar 2018 The phase 1b KEYNOTE-029 study (ClinicalTrials. NCT01704287. Stop development. PLEASE REFER TO SOLID TUMORS CLINICAL TRIAL LIST FOR MORE OPTIONS. ca. gov, NCT02089685) included independent pembrolizumab plus reduced-dose  6 Jul 2017 Safety and Tolerability of Pembrolizumab (MK-3475) + Pegylated Interferon Alpha-2b and Pembrolizumab+ Ipilimumab in Participants With Renal Cell Carcinoma. 2. Treatments, pembrolizumab, pegifn-2b, ipilimumab. [NCT02950766]. CT-011. 15 Jan 2016 Cutaneous melanoma is one of the most aggressive forms of skin cancer, and is correlated with a large proportion of skin cancer-related deaths. gov Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other  We explored the safety and preliminary antitumor activity of pembrolizumab combined with either ipilimumab or PEG-IFN in patients with advanced melanoma or RCC. Start date, March 2014