Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT)

Background:
Combination immunotherapy techniques are being explored to improve responses and enhance benefits in people with cancer. Researchers want to see if this type of treatment can help people with advanced solid tumors.
Objective:
To find a safe dose of SX-682 in combined treatment with Bintrafusp alfa and BN-CV301 vaccines and to see if this treatment will cause tumors to shrink.
Eligibility:
Adults age 18 and older with metastatic cancer may be eligible for the first part of the trial. Adults age 18 and older with metastatic triple negative breast cancer or p16 negative head and neck squamous cell cancer, and who are not candidates for curative surgery may be eligible for the second part of the trial.
Design:
Participants will be screened under a separate protocol.
Participants may have tumor biopsies. They will have physical exams. Their symptoms and medicines will be reviewed. They will have blood tests. They will have electrocardiograms to evaluate their heart.
Participants will have imaging scans of the chest, abdomen, and pelvis. They may have a procedure where a small tube with a tiny video camera is put into the nose to look at the throat if they have head and neck cancers.
Participants will get bintrafusp alfa through an intravenous catheter. For this, a small tube is put into an arm vein. They will get BN-CV301 vaccines as injections in the arm or thigh. They will take SX-682 by mouth twice a day. They will take the study drugs up to 2 years. They will keep a medicine diary.
Participants will have study visits every 2 weeks. They will have 1 or 2 follow-up visits within 30 days after they stop treatment. Then they will be monitored by phone or email for 2 years.

开始日期2020-11-24

申办/合作机构

National Cancer Institute

NCT04491955

/ Completed临床2期IIT

Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers

Background:
Metastatic or refractory/recurrent small bowel and colorectal cancers cannot be cured and are often not helped by standard treatments. Researchers want to find better treatments by testing a combination of drugs.
Objective:
To learn if a new combination of immunotherapy drugs can shrink tumors in people with advanced small bowel and colorectal cancers.
Eligibility:
People ages 18 and older who have advanced metastatic or refractory/recurrent small bowel and/or colorectal cancer.
Design:
Participants will be screened on a separate protocol. They will have a physical exam and medical history. They will have imaging scans. They will have blood and urine tests. Their heart function will be measured. They may have a tumor biopsy.
Participants will repeat some of the screening tests during the study.
Participants will be put into study groups. Each group will get a combination of the following drugs: CV301 vaccine (modified vaccinia Ankara (MVA)-BN-CV301 and Fowlpox (FPV)-CV301), M7824 (MSB0011359C), and N-803 (Anktiva). Some will also get NHS-IL12 (M9241).
Participants will get the CV301 vaccines by injection under the skin. They will get M7824 by intravenous infusion every 2 weeks. They will get N-803 by injection under the skin every 2 or 4 weeks. They may get NHS-IL12 by injection under the skin every 4 weeks. They will take the study drugs for up to 1 year. They will visit the National Institutes of Health (NIH) every 2 weeks.
After treatment ends, participants will go to the clinic for a 28-day follow-up visit or have a telephone call. They will be contacted every 3 months for 1 year, and then every 6 months after that for the rest of their life.

开始日期2020-09-22

申办/合作机构

National Cancer Institute

NCT03628716

/ Completed临床2期

A Phase 2, Multicenter, Single-Arm Trial of CV301 in Combination With PD-1/L1 Blockade in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

This is a Phase 2, single-arm, multi-institutional clinical trial designed to study the combination of CV301 with atezolizumab in the first-line treatment of UC not eligible for cisplatin-containing chemotherapy (Cohort 1) and in the second-line treatment of UC previously treated with standard first-line cisplatin-based chemotherapy (Cohort 2).

开始日期2018-09-18

申办/合作机构

Bavarian Nordic A/S

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2025-11-01·UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS

Bacillus Calmette-Guérin (BCG) in combination with PANVAC™ vs. BCG alone in adults with high-grade BCG-refractory non-muscle-invasive bladder cancer

Article

作者: Dolan, Rebecca ; Navarro, Cesar Pico ; Telfer, Siobhan ; Apolo, Andrea B ; Elsamra, Sammy E ; Agarwal, Piyush K ; Donahue, Renee N ; Schlom, Jeffrey ; Jang, Thomas L ; Saoud, Ragheed ; Singer, Eric A ; Weiss, Robert E ; Stamatakis, Lambros ; Tremblay, Samuel ; Merino, Maria ; Dahmen, Aaron ; Rodriquez, Beatriz Walter ; Ho, Matthew ; Maruf, Mahir ; Bellfield, Sonia ; Gulley, James L ; Railkar, Reema ; Lazarovich, Alon ; Valera, Vladimir ; Shih, Joanna

PURPOSE:

We postulated that PANVAC™, a recombinant poxviral vector vaccine, could enhance the immunologic and clinical response to an additional induction course of bacillus Calmette-Guérin (BCG) in patients with recurrent high-grade non-muscle-invasive bladder cancer (NMIBC).

METHODS:

This was a randomized, open-label, prospective, phase II study in subjects with high-grade NMIBC who had failed at least 1 induction course of intravesical BCG. Patients were randomized to either BCG alone or BCG+PANVAC. All subjects received intravesical BCG for 6 weeks. Patients in the combination arm also received priming and booster doses of PANVAC. The primary endpoint was recurrence-free survival. Secondary endpoints included progression-free survival and radical cystectomy-free survival. We also evaluated exploratory secondary immunological response endpoints.

RESULTS:

Our study concluded based on preplanned futility analysis. Overall, 32 patients were enrolled; 2 withdrew. Thirty patients (15/arm) were analyzed; 5 (33.3%) in the BCG-alone arm and 5 (33.3%) in the BCG+PANVAC arm met criteria for BCG- unresponsive disease. 12-month recurrence-free survival was 53.3% for the BCG-alone arm and 40% for the BCG+PANVAC arm. Overall recurrence rate at any time point was 73.3% at a median of 10.8 months, for an overall recurrence rate of 66.7% in the BCG-alone arm and 80% in the BCG+PANVAC arm. There was no difference in median recurrence-free survival or progression-free survival.

CONCLUSIONS:

This phase II study demonstrated no improvement in recurrence-free survival with BCG+PANVAC compared to BCG alone in patients with NMIBC who failed to respond to intravesical BCG.

2023-03-01·Cancer immunology, immunotherapy : CII

Phase II trial of CV301 vaccine combined with atezolizumab in advanced urothelial carcinoma

Article

作者: Kilbridge, Kerry L ; McGregor, Bradley Alexander ; Montgomery, Robert B ; Cheng, Heather H ; Maughan, Benjamin Louis ; Jain, Rohit ; Wei, Xiao X ; Perschy, Teresa ; Gafoor, Zarina ; Grewal, Jaspreet S ; Schweizer, Michael Thomas ; Lee, Richard J ; Hsieh, Andrew Caleb ; Sonpavde, Guru P ; Grivas, Petros ; Pico-Navarro, Cesar ; Yu, Evan Y

CV301 comprises recombinant poxviruses, Modified Vaccinia Ankara (MVA) and Fowlpox (FPV), encoding CEA, MUC-1, and co-stimulatory Molecules (TRICOM) ICAM-1, LFA-3, and B7-1. MVA-BN-CV301 is used for priming and FPV-CV301 is used for boosting. A Phase 2, single-arm trial was designed to evaluate CV301 plus atezolizumab as first-line treatment for cisplatin-ineligible advanced urothelial carcinoma (aUC) (Cohort 1) or progressing after platinum chemotherapy (Cohort 2). MVA-CV301 was given subcutaneously (SC) on Days 1 and 22 and FPV-CV301 SC from day 43 every 21 days for 4 doses, then tapered gradually over up to 2 years. Atezolizumab 1200 mg IV was given every 21 days. The primary endpoint was objective response rate (ORR). Overall, 43 evaluable patients received therapy: 19 in Cohort 1; 24 in Cohort 2; nine experienced ≥ Grade 3 therapy-related adverse events. In Cohort 1, one had partial response (PR) (ORR 5.3%, 90% CI 0.3, 22.6). In Cohort 2, 1 complete response and 1 PR were noted (ORR 8.3%, 90% CI 1.5, 24.0). The trial was halted for futility. Patients exhibiting benefit demonstrated T-cell response to CEA and MUC-1. The trial illustrates the challenges in the development of vaccines, which should be guided by robust preclinical data.

2023-02-01·International journal of cancer

Phase 1 trial of CV301 in combination with anti‐PD‐1 therapy in nonsquamous non‐small cell lung cancer

Article

作者: Menius, Erika ; Schlom, Jeffrey ; Devarakonda, Siddhartha ; Rajan, Arun ; Gulley, James L. ; Korchin, Borys ; Donahue, Renee N. ; Birhiray, Ruemu ; Gray, Jhanelle E.

Abstract:

CV301, a poxviral‐based vaccine, has been evaluated in a phase 1 clinical trial (NCT02840994) and shown to be safe and immunologically active (phase 1a). Preclinical data support a combination of CV301 with programmed death‐1 inhibitors, which has been evaluated in the phase 1b part of this trial and is reported here. Patients with advanced nonsquamous non‐small cell lung cancer (NSCLC) without actionable genomic alterations received two priming doses of modified vaccinia Ankara‐BN‐CV301 (MVA) 4 weeks apart, followed by boosting doses of fowlpox‐CV301 (FPV) at increasing time intervals for a maximum of 17 doses in combination with nivolumab for cohort 1 (C1) and 15 doses in combination with pembrolizumab for cohort 2 (C2). The primary objective was evaluation of safety and tolerability. Between October 2017 and September 14, 2018, patients were enrolled (C1: 4; median age: 64 years). Mean treatment duration was 332 days in C1 and 289 days in C2. CTCAE ≥grade 3 adverse events (AEs) were observed in four (100%) patients in C1 and three (37.5%) patients in C2. There was one death on trial. Immune‐related AEs (irAEs) fulfilling criteria for a dose‐limiting toxicity included 1 case of pneumonitis. Among 11 evaluable patients, 1 (9%) had a complete response, 1 (9%) had a partial response and 9 (82%) had stable disease. We conclude that CV301 administered with PD‐1 inhibitors is safe and clinically active in patients with advanced NSCLC. The frequency or severity of AEs is not increased, including irAEs for each component of the combination.

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2025-12-25

·今日头条

晚期肺鳞癌免疫治疗“破局”：新兴策略绘就未来治疗新格局（下）

继上篇探讨晚期肺鳞状细胞癌（LUSC）分子与免疫微环境特征、新型免疫检查点抑制剂（ICI）及ICI联合治疗策略之后，本文将基于综述《Emerging Options and Future Strategies in Immunotherapy for Advanced Lung Squamous Cell Carcinoma》 [1] ，深度聚焦LUSC免疫治疗更具创新性的前沿疗法：从多特异性抗体（msAb）的多靶点协同破局，到抗体偶联药物（ADC）融合靶向递送与强效杀伤的双重机制；从过继细胞转移（ACT）的个体化治疗，到癌症疫苗的精准探索。同时，文章将剖析当前LUSC药物研发面临的困境，并前瞻未来发展方向，以期全景呈现LUSC免疫治疗的新格局与新机遇。多特异性抗体：多靶点协同破局 msAb通过其独特的工程化设计，能够同时靶向两个或多个抗原或表位，从而实现协同增效，并有望降低联合用药的毒性。目前正在研发中的msAb主要包括PD-(L)1/CTLA-4双特异性抗体、PD-(L)1/VEGF双特异性抗体和PD-1/IL-2双特异性融合蛋白，以及PD-1/TIGIT双特异性抗体等其他msAb。尽管针对LUSC的特异性临床数据仍较为有限，但多项 msAb已在早期研究中展现出令人鼓舞的前景（图3）。例如，PD-(L)1/CTLA-4 双抗 KN046 和 cadonilimab、PD-1/VEGF 双抗 Ivonescimab，以及 PD-1/IL-2 双特异性融合蛋白 IBI363 均在相关临床试验中取得了积极结果 [2-5] 。此外，靶向PD-1/TIGIT、PD-1/LAG-3 和 PD-1/TIM-3 的双特异性抗体也在早期研究中显示出初步的抗肿瘤活性和可控的安全性特征 [6-8] 。新兴的三特异性抗体也正在涌现，如GB263T（靶向 EGFR/c-MET/c-MET）、NM21-1480（靶向 PD-L1/4-1BB/HSA）和 HC010（靶向 PD-1/CTLA-4/VEGF），这些分子在临床前模型中已展现出克服抗 PD-1 耐药性的潜力 [9-11] 。总之，得益于其优化的结构设计与多靶点协同机制，msAb往往较传统单克隆抗体联合疗法具有更优的安全性和更强的抗肿瘤潜能，为 LUSC 等难治性肿瘤的免疫治疗开辟了新路径。图1. 治疗晚期LUSC的新兴双特异性抗体/融合蛋白各种双特异性抗体/融合蛋白正在被积极探索，旨在通过同时靶向肿瘤生长通路与免疫检查点，协同增强晚期 LUSC 的免疫治疗效果。抗体偶联药物：靶向递送与强效杀伤双重机制探索 ADC通过将细胞毒性药物精准递送至肿瘤细胞，提供了一种靶向治疗策略，旨在降低传统化疗的全身毒性。在LUSC中，多个靶点的ADC被广泛研究。其中，TROP-2 是一种参与调控细胞增殖、侵袭和自我更新的钙信号转导蛋白，在包括 LUSC 在内的多种肿瘤中过表达，因而成为 ADC 开发的重要靶点。目前，已在晚期 LUSC 中评估的 TROP-2 靶向 ADC 包括 sacituzumab govitecan（SG）和 SKB264/MK-2870等，但不同 TROP-2 ADC 的临床疗效存在较大差异。靶向B7-H3 的 ADC 是另一个极具前景的方向。B7-H3 在多种实体瘤（包括 LUSC）中高表达，而在正常组织中表达有限。研究显示，MGC018 和 7MW3711 均可在经治 LUSC 患者中诱导肿瘤缩小 [12, 13] ；其中，7MW3711 在 B7-H3 高表达（H-score >5）患者中取得了 37.5% 的客观缓解率（ORR）和 87.5% 的疾病控制率（DCR） [13] 。此外，YL201、BNT324 和 DS-7300 等 B7-H3 靶向 ADC 也在 LUSC 中展现出一定抗肿瘤活性，尽管其整体疗效仍低于其他肺癌亚型。值得注意的是，PD-L1 本身也已成为 ADC 的靶标。例如 SGN-PDL1V 和 HLX43 等 PD-L1 靶向 ADC 不仅可阻断 PD-1/PD-L1 免疫检查点通路，还能将细胞毒性载荷精准递送至肿瘤细胞，在经治 LUSC 患者中已显示出初步疗效和可控的安全性。此外，针对 EGFR、c-MET 和 HER2 等靶点的 ADC 也在 LUSC 中中有所探索，但疗效不一。尽管ADC 在肺癌治疗领域展现出广阔前景，但其在 LUSC 中的整体疗效仍显不足。一个关键因素可能是 LUSC肿瘤免疫微环境（TIME）中高度致密的间质特征，阻碍了 ADC 向肿瘤的有效渗透，未来需要更深入地研究ADC在LUSC复杂微环境中的药代动力学特征，包括内化、转运和清除机制。过继细胞转移与癌症疫苗：个体化免疫治疗的曙光 ACT的典型策略包括细胞因子诱导杀伤（CIK）细胞疗法、嵌合抗原受体T细胞（CAR-T）疗法和肿瘤浸润淋巴细胞（TIL）疗法，这些方法在 LUSC 治疗中已初显潜力。 CIK细胞是一类共表达CD3和CD56的独特的免疫细胞群，可通过穿孔素/颗粒酶途径、Fas/FasL介导的细胞凋亡以及细胞因子（IFN-γ和TNF-α）分泌等多种机制发挥抗肿瘤作用。一项随机2期试验显示，在初治LUSC患者中，CIK细胞疗法联合化疗相较于单纯化疗，显著延长患者的中位无进展生存期（PFS：8.7个月 vs 4.0个月）和总生存期（OS：21.0个月 vs 10.3个月），并大幅提高了ORR（62.2% vs 31.1%） [14] 。 CAR-T细胞疗法涉及对患者T细胞进行基因工程改造，使其表达能够以主要组织相容性复合体（MHC）非依赖的方式识别肿瘤抗原的CARs。CARs包含一个胞外抗原结合域、一个跨膜区以及细胞内信号传导区域，以增强T细胞的激活和细胞毒作用。CAR-T疗法在肺癌中的研仍处于早期阶段，针对 LUSC 的数据有限。目前探索主要聚焦于靶向 EGFR、B7-H3 和 TROP-2 等抗原的 CAR-T 细胞，临床前研究虽展现出一定前景，但临床数据十分匮乏。 TIL疗法是从患者肿瘤中分离、扩增并回输具有天然肿瘤反应性的T细胞。然而，其在LUSC中的数据并不乐观。在一项1期研究中，TIL联合纳武利尤单抗治疗20例PD-1抑制剂耐药的非小细胞肺癌（NSCLC），整体中位肿瘤缩小35%，但其中4例LUSC患者均未产生应答 [15] 。在2期IOV-COM-202研究中，Lifileucel针对免疫治疗进展的NSCLC取得21.4%的ORR，但LUSC亚组的疗效数据尚未公布 [16] 。癌症疫苗旨在激发机体对肿瘤抗原的特异性免疫应答。OSE2101是一种针对5种肿瘤相关抗原（TAA）的多肽疫苗，在2期ATALANTE-1试验的事后分析中，相较于化疗，显著改善了经免疫治疗和化疗后进展的晚期NSCLC患者的总生存，且LUSC患者的获益趋势更明显 [17] 。此外，其他疫苗如BNT116、CIMAvax-EGF, UCPVax和IO102-IO103等，也在 NSCLC 中展现出初步潜力，值得进一步探索。 LUSC免疫治疗：挑战与希望免疫疗法已成为LUSC治疗的基石，各类新兴疗法不断涌现（图4）。然而，针对这一特定亚型的药物研发仍面临重大挑战，例如LUSC TMIE高度致密的间质特性限制了药物的渗透，肿瘤内部高度异质性促进了抗原逃逸，而TMIE免疫抑制则削弱了有效的细胞毒性反应。此外，现有证据多源于宽泛的NSCLC研究，LUSC样本量小或仅限事后亚组分析。这一现状凸显了开展聚焦LUSC的转化医学与临床研究的迫切需求。展望未来，LUSC免疫治疗将沿四大方向演进：多靶点治疗策略、增强免疫细胞浸润和细胞毒作用的生物免疫疗法、创新技术驱动的个体化免疫治疗，以及免疫治疗再挑战。与此同时，多种新型免疫治疗药物及联合方案正在 LUSC 患者中积极开展临床研究，有望提供比ICI再挑战更为有效的治疗选择。图2. 晚期LUSC新兴免疫治疗策略令人鼓舞的结果主要分为四类：ICI联合治疗、bsAb/融合蛋白、ADC和CIK细胞治疗&癌症疫苗。总结晚期LUSC的免疫治疗正迎来多重创新突破，包括msAb/融合蛋白、ADC、ACT和癌症疫苗等，均在积极探索之中，并展现出广阔的应用前景。目前，突破TIME介导的免疫抑制和肿瘤异质性仍是核心挑战，亟需深入探索有效的多靶点和基于生物学机制的治疗策略。随着多组学与人工智能技术的快速发展，将有助于更精细地解析 LUSC 的分子与免疫特征，从而优化治疗决策，推动个体化治疗以实现长期生存获益。参考文献： [1] Wang Y, Rosell R, Hirsch FR, et al. Emerging Options and Future Strategies in Immunotherapy for Advanced Lung Squamous Cell Carcinoma. Ann Oncol. 2025 : S0923-7534(25)06266-0. [2] Zhao Y, Chen G, Li X, et al. KN046, a bispecific antibody against PD-L1 and CTLA-4, plus chemotherapy as first-line treatment for metastatic NSCLC: A multicenter phase 2 trial. Cell Rep Med. 2024. 5(3): 101470. [3] Zhao Y, Ma Y, Fan Y, et al. A multicenter, open-label phase Ib/II study of cadonilimab (anti PD-1 and CTLA-4 bispecific antibody) monotherapy in previously treated advanced non-small-cell lung cancer (AK104-202 study). Lung Cancer. 2023. 184: 107355. [4] Chen Z, Yang F, Jiang Z, et al. Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (HARMONi-6): a randomised, double-blind, phase 3 trial. Lancet. 2025. 406(10515): 2078-2088. [5] Zhou J, Bai X, Chen Y, et al. First-in-class PD-1/IL-2 bispecific antibody IBI363 in patients (Pts) with advanced immunotherapy-treated non-small cell lung cancer (NSCLC). Journal of Clinical Oncology 2025; 43 (16_suppl): 8509-8509 . [6] Hiltermann TJN, Izumi H, Cho BC, et al. OA11.03 Efficacy and Safety of Rilvegostomig, an Anti-PD-1/TIGIT Bispecific, for CPI-naïve Metastatic NSCLC with PD-L1 1-49% or ≥50%. Journal of Thoracic Oncology 2024; 19 (10): S33 . [7] Nadal E, Rittmeyer A, De Marinis F, et al. 7MO: A phase II trial of tobemstomig (tobe) + platinum-based chemotherapy (chemo) vs pembrolizumab (pembro) + chemo in patients (pts) with untreated locally advanced or metastatic non-small cell lung cancer (NSCLC). Journal of Thoracic Oncology 2025; 20 (3): S11-S12 . [8] Besse B, Italiano A, Cousin S, et al. 1313MO Safety and preliminary efficacy of AZD7789, a bispecific antibody targeting PD-1 and TIM-3, in patients (pts) with stage IIIB–IV non-small-cell lung cancer (NSCLC) with previous anti-PD-(L)1 therapy. Annals of Oncology 2023; 34: S755 . [9] Yang JJ, Pavlakis N, Xie F, et al. 1272P Updated results from a first-in-human, phase I/II study of GB263T, a novel EGFR/cMET/cMET tri-specific antibody, in patients with advanced EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC). Annals of Oncology 2024; 35: S813 . [10] Jason L, Melissa J, Shirish G, et al. 732 First-in-human trial to evaluate safety, PK/PD and initial clinical activity of NM21-1480, an affinity-balanced PD-L1x4-1BBxHSA trispecific antibody: results of phase 1 dose escalation. Journal for ImmunoTherapy of Cancer 2022;10 (Suppl 2) . [11] Jiang D, Xi Y, Xu C, et al. Abstract 2726: A novel trispecific antibody HC010 targeting PD-1/CTLA-4/VEGF for the potential treatment in anti-PD-1 antibody resistant NSCLC patients. Cancer Research 2024; 84 (6_Supplement): 2726-2726 . [12] Shenderov E, Mallesara GHG, Wysocki PJ, et al. 620P MGC018, an anti-B7-H3 antibody-drug conjugate (ADC), in patients with advanced solid tumors: Preliminary results of phase I cohort expansion. Annals of Oncology 2021; 32: S657-S659 . [13] Li. Z, Wang. Q, Han. L, et al. Results from a phase 1/2 study of 7MW3711: A novel B7-H3 antibody-drug conjugate (ADC) incorporating a topoisomerase I inhibitor in patients with lung cancer. 2025 ASCO Annual Meeting. Abstract 3035 . [14] Liu L, Gao Q, Jiang J, et al. Randomized, multicenter, open-label trial of autologous cytokine-induced killer cell immunotherapy plus chemotherapy for squamous non-small-cell lung cancer: NCT01631357. Signal Transduct Target Ther. 2020. 5(1): 244. [15] Creelan BC, Wang C, Teer JK, et al. Tumor-infiltrating lymphocyte treatment for anti-PD-1-resistant metastatic lung cancer: a phase 1 trial. Nat Med. 2021. 27(8): 1410-1418. [16] Schoenfeld AJ, Lee SM, Doger de Spéville B, et al. Lifileucel, an Autologous Tumor-Infiltrating Lymphocyte Monotherapy, in Patients with Advanced Non-Small Cell Lung Cancer Resistant to Immune Checkpoint Inhibitors. Cancer Discov. 2024. 14(8): 1389-1402. [17] Besse B, Felip E, Garcia Campelo R, et al. Randomized open-label controlled study of cancer vaccine OSE2101 versus chemotherapy in HLA-A2-positive patients with advanced non-small-cell lung cancer with resistance to immunotherapy: ATALANTE-1. Ann Oncol. 2023. 34(10): 920-933. 本文由阿斯利康提供，仅供医疗卫生专业人士参考，不可用于推广目的。审批号：CN-175111 有效期：2026-03-17

免疫疗法抗体药物偶联物疫苗临床研究

2016-08-15

·BioSpace

Bristol-Myers Squibb Investors: Wait on Opdivo Data to See Potential in Lung Cancer

August 15, 2016 By Alex Keown , BioSpace.com Breaking News Staff NEW YORK – The details are in the data, not the headlines. That’s the message a Seeking Alpha contributor has regarding Bristol-Myers Squibb ‘s recent trial failure of Opdivo. The contributor, who writes under the pen name Pharma Doc, a self-described Ph.D. at a “major pharmaceutical company” said that despite the nearly 20 percent drop in stock price for Bristol-Myers, he continues to believe the stock is a strong buy. He said he believes investors and analysts have overreacted as far as Opdivo and maintains the drug is still a high value driver for the company. Earlier this month, BMS announced Opdivo failed to meet its endpoints in a Phase III trial as a monotherapy for a “broad patient population” in patients with previously untreated advanced non-small cell lung cancer. The company said the drug failed to meet its endpoints of progression-free survival in patients expressing PD-L1 at 5 percent. However, Pharma Doc noted that Opdivo has a strong record of working well in patients who have higher levels of PD-L1 expression. Following the announcement, BMS stock fell, while rival Merck jumped as investors looked to that company’s PD-L1 targeting drug, Keytruda, which recently posted its own successful trial results. However, that may have been due to better trial design, as Keytruda was being used to evaluate patients expressing 50 percent PD-1 and not 5 percent, as the Opdivo trial. Pharma Doc noted that when BMS releases the trial data, investors will likely see the drug for its potential in treating lung cancer. In a Motley Fool podcast, analysts said it’s likely that Opdivo and Keytruda stack up well to each other when it’s an apples to apples comparison of patients with similar PD-1 expressions. In December 2014, Opdivo was approved by the U.S. Food and Drug Administration for patients with advanced melanoma who no longer respond to other drugs, or cannot be treated via surgery. In March 2015, it was approved for treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Opdivo is an immuno-therapy drug delivered via injection that harnesses the patient’s own immune system to fight cancerous cells. Opdivo works by inhibiting the cellular pathway known as PD-1 protein on cells that blocks the body’s immune system from attacking cancerous cells. Since the trial failure though, Bristol-Myers continues to study Opdivo as a cancer treatment. This morning the company entered into a developmental partnership with Bavarian Nordic to study a combination therapy of Opdivo and Bavarian Nordic’s experimental cancer therapy, CV301. Bavarian Nordic’s therapy has been shown to upregulate PD-L1, suggesting its ability to stimulate an immune attack to cancer and the potential benefit of an anti-PD-1 antibody. Under the new collaboration, BMS will supply OPDIVO for a Phase 2 clinical study in combination with CV301 to treat patients with non-small cell lung cancer. Opdivo has an advantage over Keytruda, which requires patients pass a regulatory diagnostic before being prescribed the medication. BMS’ treatment does not have that restriction, which may make it preferable to prescribe.

临床3期临床2期上市批准免疫疗法

100 项与 Cancer vaccine(Therion Biologics Corp.) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
转移性胰腺癌	临床3期	美国	Therion Biologics Corp.	2004-06-01
肝转移	临床2期	美国	National Cancer Institute	2020-11-24
局部晚期恶性实体瘤	临床2期	美国	National Cancer Institute	2020-11-24
小肠癌	临床2期	美国	National Cancer Institute	2020-09-22
局部晚期膀胱癌	临床2期	美国	Bavarian Nordic A/S	2018-09-18
转移性胰腺腺癌	临床2期	美国	Bavarian Nordic A/S	2018-08-08
转移性胰腺腺癌	临床2期	美国	MedImmune LLC	2018-08-08
转移性结直肠癌	临床2期	美国	Bavarian Nordic A/S	2018-06-26
非小细胞肺癌	临床2期	美国	Bavarian Nordic, Inc.	2017-04-30
浸润性膀胱癌	临床2期	美国	National Cancer Institute	2013-12-18

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04491955 (Pubmed \| Oncologist)	临床1/2期	转移性结直肠癌 pMMR	32	CV-301 + N-803 + bintrafusp alfa + PDS01ADC	選遞襯繭淵廠簾醖醖網(艱蓋鹽糧窪艱憲顧顧築) = 鏇積膚廠餘簾構築鬱願膚膚齋壓鏇艱顧簾積糧 (積網膚製鹹糧廠簾壓遞 ) 更多	不佳	2026-01-10
NCT03547999 (HCRN GI16-288, CTgov)	临床2期	转移性结直肠癌	17	Nivolumab+LEUCOVORIN CALCIUM+Oxaliplatin+Fluorouracil (Arm A - Control)	膚積繭壓鏇醖顧築淵獵 = 襯窪夢積積廠艱齋遞願衊觸構餘蓋網齋觸顧廠 (餘遞鏇艱襯醖鬱壓顧齋, 網構獵壓網衊餘襯構艱 ~ 餘鹹淵鹽窪窪壓壓衊艱) 更多	-	2025-07-22
				FPV-CV301+Nivolumab+MVA-BN-CV301+LEUCOVORIN CALCIUM+Oxaliplatin+Fluorouracil (Arm B - Experimental)	膚積繭壓鏇醖顧築淵獵 = 蓋糧壓選簾範醖鏇顧築衊觸構餘蓋網齋觸顧廠 (餘遞鏇艱襯醖鬱壓顧齋, 襯醖繭窪觸襯衊襯憲簾 ~ 鏇齋鑰齋獵夢鬱餘淵壓) 更多
NCT04491955 (CTgov)	临床2期	结直肠癌 \| 小肠癌	32	NHS-IL12 (M9241) (Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241))	構鬱積網餘襯齋蓋鹽顧 = 淵顧壓鏇壓齋觸觸鬱遞膚鹽願鏇觸製淵鏇餘遞 (廠願獵鏇製醖壓鏇選糧, 顧積蓋夢窪觸獵壓鏇選 ~ 製膚餘廠範範顧鏇憲構) 更多	-	2023-11-14
				Fowlpox (FPV)-CV301+N-803+MVA-BN-CV301+M7824+NHS-IL12 (M9241) (Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation)	構鬱積網餘襯齋蓋鹽顧 = 糧構願壓鬱鏇餘齋淵簾壓齋廠窪繭簾鏇膚鏇糧 (觸夢獵憲繭構鏇選餘製, 簾積鏇選鑰鏇艱選廠範 ~ 繭鹽蓋願鹹襯觸網鹹窪) 更多
NCT04574583 (CTgov)	临床1/2期	局部晚期恶性实体瘤 \| 肝转移 \| 转移性肿瘤 ... 更多	12	recombinant fowlpox viral (FPV)-CV301+MVA-BN-CV301+M7824+SX-682 (Phase I Dose Level 1(DL1) 25mg SX-682 Monotherapy Sequentially Foll/by 1200mg BinTraFusp Alfa +CV301)	簾觸衊遞齋淵積築選鬱 = 顧淵艱淵築簾壓鏇鏇淵壓壓艱構鏇窪網齋餘鹽 (鑰鹽醖積鏇鑰膚壓艱鹹, 選衊鑰鹹窪鏇鑰憲積鏇 ~ 憲齋構鏇鑰獵夢遞構顧) 更多	-	2023-05-03
				recombinant fowlpox viral (FPV)-CV301+MVA-BN-CV301+M7824+SX-682 (Phase I Dose Level 2 (DL2) 50 mg SX-682 Sequentially Followed by 1200mg BinTraFusp Alfa + CV301)	簾觸衊遞齋淵積築選鬱 = 鏇鬱鏇積積壓構鹽積構壓壓艱構鏇窪網齋餘鹽 (鑰鹽醖積鏇鑰膚壓艱鹹, 網膚鑰壓膚鹹襯積鬱衊 ~ 鑰餘簾鬱夢糧願齋鏇範) 更多
NCT03547999 (HCRN GI16-288, ASCO_GI2023) 人工标引	临床2期	转移性结直肠癌一线 MSS	17	mFOLFOX + nivolumab	憲齋網廠顧蓋鹽選製獵(鏇製蓋淵簾製憲網鹽鹽) = 廠艱鬱築鑰衊齋鹽淵餘遞製蓋廠鹽簾襯廠觸簾 (簾範網製獵醖醖艱願簾 ) 更多	积极	2023-01-24
				mFOLFOX + nivolumab + CV301	憲齋網廠顧蓋鹽選製獵(鏇製蓋淵簾製憲網鹽鹽) = 觸遞鏇簾獵醖網壓遞鏇遞製蓋廠鹽簾襯廠觸簾 (簾範網製獵醖醖艱願簾 ) 更多
NCT04491955 (ASCO_GI2023) 人工标引	临床2期	晚期结直肠腺癌 \| 小肠癌二线	30	overall	餘選夢鏇鹽繭壓構願齋(廠遞憲廠願構繭鏇艱餘) = 鏇選鹹衊製艱築壓憲窪獵構窪鑰醖簾繭鬱醖顧 (壓遞選顧選鑰艱獵醖襯 )	积极	2023-01-24
				CV301+N-803+bintrafusp alfa (triple therapy)	糧淵壓願糧簾鹹遞襯淵(構齋糧襯餘襯壓鏇獵簾) = 醖鏇憲醖餘鹽鹽窪築壓鏇遞廠鹹鹽鹽艱製憲餘 (艱襯鏇醖衊糧窪構憲窪, 33.7 ~ 86.0) 更多
NCT03376659 (CTgov)	临床1/2期	大肠腺癌 \| 转移性胰腺腺癌 \| 转移性胰腺癌 ... 更多	8	CV301+Bevacizumab+Durvalumab+Capecitabine	蓋糧齋壓壓觸醖衊獵範(壓衊憲選網壓壓糧選構) = 夢餘鬱積醖簾淵築鏇選鏇獵蓋廠積襯襯築構艱 (製製築鬱顧壓壓顧襯廠, 憲獵憲遞網鏇齋範積淵 ~ 餘製簾製繭繭廠網製繭) 更多	-	2023-01-10
NCT03628716 (CTgov)	临床2期	局部晚期膀胱癌 \| 膀胱癌	43	CV301+Atezolizumab (CV301 + Atezolizumab (Cohort 1))	膚鏇獵製餘網壓鏇獵餘 = 遞積鬱鬱簾壓憲衊鏇鬱廠選蓋齋簾夢製鬱積範 (壓艱衊繭壓餘網鏇鹹鬱, 夢製鑰蓋醖範獵膚積齋 ~ 積鑰糧顧蓋襯鏇觸鑰醖) 更多	-	2022-04-27
				CV301+Atezolizumab (CV301 + Atezolizumab (Cohort 2))	膚鏇獵製餘網壓鏇獵餘 = 膚衊鏇鹽壓淵鏇襯遞窪廠選蓋齋簾夢製鬱積範 (壓艱衊繭壓餘網鏇鹹鬱, 遞構蓋網顧簾憲淵選襯 ~ 憲襯選衊築簾襯憲壓餘) 更多
NCT03628716 (ASCO_GU2022)	临床2期	晚期尿路上皮癌	43	CV301 vaccine plus atezolizumab	蓋淵積選選遞鹽齋製範(網壓範製窪鹹簾鹹艱鹽) = 壓願蓋構夢夢願築製範範鹹襯壓製積醖壓憲積 (艱構願鹽醖選糧觸夢衊, 0.3 ~ 22.6) 更多	不佳	2022-02-16
NCT02015104 (CTgov)	临床2期	浸润性膀胱癌 \| 非肌层浸润性膀胱肿瘤	32	Bacillus Calmette-Guerin+PANVAC (Bacillus Calmette-Guerin (BCG) + PANVAC)	醖積鏇襯淵選願鏇餘餘 = 淵鹽鏇築願衊窪壓壓壓窪淵簾醖鑰製鑰膚衊餘 (窪衊襯餘淵獵淵觸醖鑰, 網淵膚糧繭遞窪鹹醖選 ~ 構範顧範鏇獵築鹽窪獵) 更多	-	2020-01-22
				Bacillus Calmette-Guerin (Bacillus Calmette-Guerin (BCG) Alone)	醖積鏇襯淵選願鏇餘餘 = 壓醖餘鬱遞蓋願選糧簾窪淵簾醖鑰製鑰膚衊餘 (窪衊襯餘淵獵淵觸醖鑰, 範獵餘積鹽艱淵遞積觸 ~ 廠選顧壓簾窪構衊醖鑰) 更多