An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer in China (RAINFOL-02)
2026年9月7日 更新者：Genmab
A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Platinum Resistant Ovarian Cancer
The purpose of this Chinese extension study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer.
Treatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose.
All participants will receive active drug; no one will be given placebo.
This study is an extension study of the protocol GCT1184-02 (NCT06619236).
調査の概要
研究の種類
介入
入学 (推定)
82
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Genmab Trial Information
- 電話番号：+4570202728
- メール：clinicaltrials@genmab.com
研究場所
-
-
-
Changchun、中国
- 募集
- The First Hospital of Jilin University
-
Changsha、中国
- 募集
- Hunan Cancer Hospital
-
Chengdu、中国
- 募集
- West China Second University Hospital, Sichuan University
-
Chongqing、中国
- 募集
- Chongqing University Cancer Hospital - Chongqing Cancer Hospital
-
Guangzhou、中国
- 募集
- Sun Yat-sen University Cancer Center
-
Guangzhou、中国
- 募集
- Sun Yat-sen Memorial Hospital
-
Hangzhou、中国
- 募集
- Zhejiang Cancer Hospital
-
Harbin、中国
- 募集
- Harbin Medical University Cancer Hospital
-
Jinan、中国
- 募集
- Shandong First Medical University Affiliated Tumor Hospital
-
Nanjing、中国
- 募集
- Nanjing Drum Tower Hospital (The Affiliated Hospital of Nanjing University Medical School)
-
Shanghai、中国
- 募集
- Obstetrics & Gynecology Hospital of Fudan University
-
Shanghai、中国
- 募集
- Fudan University Shanghai Cancer Hospital
-
Shenyang、中国
- 募集
- Liaoning Cancer Hospital
-
Taiyuan、中国
- 募集
- Shanxi Cancer Hospital
-
Tianjin、中国
- 募集
- Tianjin Medical University Cancer Institute & Hospital
-
Xi'an、中国
- 募集
- The First Affiliated Hospital of Xi'an Jiaotong University
-
Zhengzhou、中国
- 募集
- Henan Cancer Hospital
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Key Inclusion Criteria:
- Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
- Participants may be enrolled regardless of FRα expression level.
- Participants must have received 1 to 4 prior lines of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.
Participants must have received prior treatment with the following therapies:
- Platinum chemotherapy
- Prior bevacizumab (or biosimilar) treatment is required, if labeled and available as standard of care per institutional guidelines, unless the participant has a documented contraindication or unless the participant is not eligible for treatment with bevacizumab (or biosimilar) due to precautions/intolerance
- Participants with known or suspected deleterious germline or somatic breast cancer gene (BRCA) mutations and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment unless the participant is not eligible for treatment with PARP inhibitor
Mirvetuximab soravtansine, if:
- Mirvetuximab soravtansine is available in the enrollment region, and
- The participant is eligible, and
- The participant does not have a documented medical exception, including chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision.
Participants must have platinum-resistant disease:
- Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, and must have either had a response (CR or PR) or had non-measurable disease at the start of adjuvant platinum-based therapy, and then progressed between > 91 days and ≤ 183 days after the date of the last dose of platinum.
- Participants who have received a protocol defined number of lines of platinum-based therapy must have progressed on or within 183 days after the date of the last dose of platinum.
Key Exclusion Criteria:
- Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.
- Have primary platinum-refractory disease, defined as ovarian cancer that did not respond (CR or PR) to or progressed ≤ 91 days after the last dose of a first-line platinum-containing regimen.
- History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer.
- Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry.
- Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past 91 days or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility.
- Participant has clinically significant ascites/pleural effusion. Enrollment of participants with an indwelling catheter flush/drain is not allowed. Note: Clinically significant is defined as (1) symptomatic, or (2) requires therapeutic paracentesis/thoracentesis within 8 weeks of the first dose, or (3) recurrent ascites/pleural effusion that necessitates multiple paracentesis/thoracocentesis procedures more often than approximately every 4 weeks.
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
アクティブコンパレータ：調査員の選択
|
点滴
点滴
点滴
点滴静注
|
|
実験的：リナS
|
静脈内（IV）注入
他の名前：
|
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 |
|---|---|---|
|
Progression-Free Survival (PFS)
時間枠：Up to approximately 16 months
|
PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator.
|
Up to approximately 16 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall Survival (OS)
時間枠：Up to approximately 25 months
|
OS is defined as the time from date of randomization to date of death due to any cause.
|
Up to approximately 25 months
|
|
Objective Response Rate (ORR)
時間枠：Up to approximately 25 months
|
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by the investigator.
|
Up to approximately 25 months
|
|
PFS as Determined by BICR
時間枠：Up to approximately 16 months
|
PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on RECIST version 1.1 as determined by BICR.
|
Up to approximately 16 months
|
|
ORR as Determined by BICR
時間枠：Up to approximately 25 months
|
ORR is defined as the percentage of participants with BOR of CR or PR based on RECIST v1.1 as determined by BICR.
|
Up to approximately 25 months
|
|
Duration of Response (DOR)
時間枠：Up to approximately 25 months
|
DOR is defined as the time from the onset date of response to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by the investigator and by blinded independent central review (BICR).
|
Up to approximately 25 months
|
|
Percentage of Participants Who Achieved Cancer Antigen-125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria
時間枠：Up to approximately 25 months
|
A CA-125 response per the GCIG criteria is defined as a ≥ 50% reduction in CA-125 levels from baseline.
|
Up to approximately 25 months
|
|
Time to Second Disease Progression or Death From any Cause (PFS2)
時間枠：Up to approximately 25 months
|
PFS2 is defined as the time from randomization to the date of the second PD (i.e., the first PD reported in subsequent anti-cancer therapies, or long-term follow up) or death.
|
Up to approximately 25 months
|
|
Overall Change From Baseline in Global Health Status/Quality of Life (GHS/Qol)
時間枠：Baseline, up to approximately 25 months
|
Overall change from baseline in GHS/Qol score (items 29 and 30) will be calculated using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC-QLQ-C30) questionnaire.
The score ranges from 0 to 100.
A high scale score represents a higher response level.
|
Baseline, up to approximately 25 months
|
|
Time to Deterioration (TTD) in the GHS/Qol Score
時間枠：Up to approximately 25 months
|
TTD in the GHS/Qol score is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) in GHS/QoL score.
A longer TTD indicates a better outcome.
|
Up to approximately 25 months
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
時間枠：Up to approximately 25 months
|
Up to approximately 25 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Study Official、Genmab
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月26日
一次修了 (推定)
2027年9月1日
研究の完了 (推定)
2028年12月1日
試験登録日
最初に提出
2026年5月18日
QC基準を満たした最初の提出物
2026年5月18日
最初の投稿 (実際)
2026年5月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月9日
QC基準を満たした最後の更新が送信されました
2026年9月7日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- GCT1184-02 Extension Study
- CTR20253987 (レジストリ識別子：ChinaDrugTrials.org.cn)
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?
いいえ
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
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。