Study of CryptiVax-1001 in Maintenance Setting for Advanced Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (OVACT)
A Phase I/Ib, Multi-centre, Open-label Study to Evaluate the Safety, Tolerability, and Immunogenicity of CryptiVax-1001, a mRNA Lipid Nanoparticle Therapeutic Cancer Vaccine, in Participants With FIGO Stage III-IV High-Grade Serous or Predominantly Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Following Optimal Primary/Interval Debulking Surgery and First-Line Platinum-Based Chemotherapy (OVACT Study)
Ovarian, fallopian tube, or primary peritoneal cancer, collectively referred to as ovarian cancer, remains the deadliest type of gynaecological cancer. The most common and aggressive form is called high-grade serous ovarian cancer.
The main purpose of this study is to understand whether an experimental study vaccine, CryptiVax-1001, is safe when administered to patients with high-grade serous ovarian cancer (HGSOC). The study vaccine is a cancer vaccine, which aims to delay or possibly prevent the cancer from coming back. However, as this is the first study of the vaccine in patients, the primary purpose of this study is to assess the safety of the study vaccine.
Following surgery and platinum-based chemotherapy participants may enter the trial and receive CryptiVax-1001 as an explorative maintenance therapy.
The main purposes of this study are therefore to:
- assess how well the study vaccine is tolerated and identify any side effects.
- analyse the study vaccine's capacity to activate your immune system
The study will test escalating dose levels of CryptiVax-1001 based on the safety evaluations to estimate appropriate future dose levels for CryptiVax-1001.
調査の概要
状態
介入・治療
詳細な説明
The OVACT study is the First in Human clinical evaluation of Cryptivax-1001 in patients with advanced high-grade serous or predominantly serous ovarian, fallopian tube, or primary peritoneal cancer, following optimal debulking surgery (R0 or R1 after either IDS or PDS), and no recurrence or progression after completion of platinum-based chemotherapy. This phase I/Ib dose escalation and expansion study will assess safety, tolerability, and immunogenicity in a population where there is a high unmet need and no clearly effective maintenance therapy options. By focusing on the BRCAwt/HRP subgroup, the study addresses the majority of patients who currently lack access to biologically-matched maintenance strategies.
The study consist of 2 parts - a dose escalation part and an optional dose expansion part
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Head of Development Operations
- 電話番号：+4530660105
- メール：Gertrud.Rasmussen@epitopea.com
研究連絡先のバックアップ
- 名前：Head of Oncology Development
- 電話番号：+4795113393
- メール：Siri.Torhaug@Epitopea.com
研究場所
-
-
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Cambridge、イギリス、CB2 0QQ
- 募集
- Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
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Edinburgh、イギリス、EH4 2XR
- まだ募集していません
- The University of Edinburgh - Western General Hospital - Edinburgh Cancer Research Centre
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Glasgow、イギリス、G12 0YN
- 募集
- Beatson West of Scotland Cancer Centre
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Leeds、イギリス、LS9 7TF
- 募集
- St. James's University Hospital
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Leicester、イギリス、LE2 7LX
- 募集
- University Hospitals of Leicester NHS Trust -Leicester Royal Infirmary
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London、イギリス、SE1 9RT
- まだ募集していません
- Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
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London、イギリス、SW3 6JJ
- 募集
- Royal Marsden NHS Foundation Trust - Royal Marsden Hospital
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London、イギリス、NW1 2PG
- 募集
- University College London Hospitals NHS Foundation Trust - Cancer Clinical Trials Unit
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Preston、イギリス、PR2 9HT
- 募集
- Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
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Sutton、イギリス、SM2 5PT
- 募集
- Royal Marsden NHS Foundation Trust - Institute of Cancer Research
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Able to comprehend and are willing to sign the ICF and willing to follow the study procedures
- Female, aged 18 years of age or older at the time of informed consent.
- Histologically confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma of high-grade serous histology or other high-grade predominantly serous subtypes
- The FIGO 2014 stage III or IV disease at initial diagnosis.
- Underwent optimal PDS or IDS with residual disease ≤1 cm (R0 or R1 resection)
- Completed first-line platinum-based chemotherapy (minimum 4 cycles of carboplatin and paclitaxel, or equivalent, received in either neoadjuvant or adjuvant, or both settings).
- In the presence of measurable target lesion, achieved CR or PR per investigator assessment based on RECIST 1.1 after completion of chemotherapy. In the absence of measurable target lesion, no new lesion or overt progression per investigator assessment based on RECIST 1.1 after completion of chemotherapy.
- A minimum of 4 weeks from screening since the last dose of first-line platinum-based chemotherapy but not more than 12 weeks from screening since the last dose of first-line platinum-based chemotherapy.
- No evidence of radiologic or clinical progression between the end of chemotherapy and baseline screening.
- Known BRCAwt status.
- HRP confirmed
- No prior, current, or planned treatment with bevacizumab or PARPi in the first-line maintenance setting.
- ECOG performance status of 0 or 1.
- Adequate haematologic and organ function
- Negative pregnancy test for WOCBP.
- HLA type matching Cryptivax-1001
Exclusion Criteria:
- Non-epithelial or low malignant potential ovarian tumours
- Presence of uncontrolled ascites or pleural effusion requiring drainage within 4 weeks of screening.
- Concurrent malignancy or history of another malignancy within the past 3 years except for malignancies with a negligible risk of metastasis or death
- Active autoimmune disease requiring systemic immunosuppression
- Uncontrolled intercurrent illness that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments
- History of anaphylactic reaction to mRNA-LNP therapies.
- Previous treatment with any cancer vaccine, checkpoint inhibitor, or adoptive cellular immunotherapy.
- Administration of any vaccine within 30 days prior to first dosing.
- Participation in a clinical study involving administration of an IMP (new chemical entity) in the past 90 days or 5 half-lives of that drug (if known) prior to first dosing, whichever is longer.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：用量レベル 1
|
i.m injection
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実験的：用量レベル 2
|
i.m injection
|
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実験的：用量レベル 3
|
i.m injection
|
|
実験的：用量レベル 4
|
i.m injection
|
|
実験的：用量レベル 5
|
i.m injection
|
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実験的：Recommended Dose
Recommended phase 2 dose or another safe dose, based on Dose Escalation part
|
i.m injection
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To evaluate the safety and tolerability of CryptiVax-1001
時間枠：Through study completion, an average of up 2 to years
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Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs) per Common Terminology Criteria for Adverse Events
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Through study completion, an average of up 2 to years
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To evaluate the safety and tolerability of CryptiVax-1001
時間枠：From Day 1 to Day 21
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Incidence and nature of dose-limiting toxicities (DLTs) during the DLT observation period
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From Day 1 to Day 21
|
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To evaluate the safety and tolerability of CryptiVax-1001
時間枠：Through study completion, an average of up to 2 years
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Clinically significant changes from baseline in vital signs (body temperature, pulse rate, respiratory rate, systolic and diastolic blood pressure)
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Through study completion, an average of up to 2 years
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To evaluate the safety and tolerability of CryptiVax-1001
時間枠：Through study completion, and average of up to 2 years
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Clinically significant changes from baseline in clinical laboratory assessments (hematology and chemistry)
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Through study completion, and average of up to 2 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To characterise the immunogenicity of Cryptivax-1001
時間枠：At pre-defined timepoints during treatment and Follow-up period, an average of up to 2 years
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Detection and quantification of antigen-specific T cells in peripheral blood at predefined timepoints
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At pre-defined timepoints during treatment and Follow-up period, an average of up to 2 years
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Susana Banerjee, MBBS MA FRCP PhD、Royal Marsden NHS Foundation Trust
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- OVCA-1
- UTN U1111-1332-3427 (その他の識別子：WHO)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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