M6223 のヒトでの最初の研究
2026年4月13日 更新者：EMD Serono Research & Development Institute, Inc.
第 I 相、ファーストインヒューマン、非盲検、複数用量漸増試験。単剤および Bintrafusp Alfa (抗PDL1/TGFβトラップ) 転移性または局所進行固形切除不能腫瘍の参加者
この研究の主な目的は、単剤としての M6223 の安全性、忍容性、薬物動態 (PK)、免疫原性 (観察された場合) の最大耐用量 (MTD) (パート 1A) を 2 週間ごと (Q2W ) レジメンと 3 週間ごと (Q3W) レジメン、および M6223 と bintrafusp alfa (パート 1B) を併用した Q2W レジメンは、転移性または局所進行性切除不能固形腫瘍の参加者を対象としています。
調査の概要
研究の種類
介入
入学 (実際)
58
段階
- フェーズ 1
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。
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
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
説明
包含基準:
- -参加者は、組織学的または細胞学的に証明された局所進行性または進行性固形悪性腫瘍であり、標準治療に難治性であるか、または標準治療下で進行しており、臨床的利益をもたらすことが知られている他の治療法の選択肢がない
- -スクリーニング時にEastern Cooperative Oncology Group Performance Status（ECOG PS）が0〜1の参加者
- -参加者は、腫瘍組織を含むホルマリン固定パラフィン包埋ブロック、または免疫組織化学に基づくタンパク質発現の染色に適した最低15枚（できれば25枚）の未染色腫瘍スライドを持っています
- -平均余命が少なくとも12週間の参加者
- -固形腫瘍バージョン1.1の応答評価基準（RECIST 1.1）に従って測定可能な疾患を有する参加者
- -プロトコルで定義されている適切な血液学的、肝臓および腎機能
- 他のプロトコル定義の包含基準が適用される場合があります
除外基準:
- -以前の治療に関連する持続的な毒性を有する参加者 グレードが（>）1より大きい 国立がん研究所有害事象の共通用語基準（NCI-CTCAE）バージョン5.0、ただし、脱毛症、感覚神経障害 グレードが（<=）2以下、またはその他の非免疫関連グレード <= 2 安全上のリスクを構成しない
- -同種幹細胞移植を含む以前の臓器移植を受けた参加者
- -免疫チェックポイント阻害剤に関連する以前の毒性のある参加者 等級（> =）3以上のNCI-CTCAEバージョン5.0 研究を含める前にグレード<= 1に解決されない限り
- -修正されたQT間隔（QTcF、フリデリシア式で修正）を含む、現在の重大な心臓伝導異常のある参加者 トリプリケート12誘導心電図で> 450ミリ秒（ms）の延長または心血管機能障害、心室頻脈、低カリウム血症または発作性心房の病歴細動、重篤な不整脈、突然死またはQT延長症候群の家族歴
- -脳血管障害/脳卒中（登録前の[<] 6か月未満）、心筋梗塞（登録前の<6か月）、不安定狭心症、うっ血性心不全などの血管、心血管または脳血管疾患の病歴（ニューヨークハート-協会分類クラス> = II）、深部静脈血栓症（登録前<3か月）または肺血栓症/塞栓症（登録前<3か月）
- 他のプロトコル定義の除外基準が適用される場合があります
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：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：パート 1A: M6223 単剤療法
|
Participants received an intravenous (IV) infusion of M6223 at escalated doses every 2 weeks (Q2W) or every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses Q2W on Day 1 of each Cycle (Each cycle is of 21 days) according to the recommendation of the SMC until the MTD has been reached or confirmed disease progression.
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実験的：Part1B: M6223 + ビントラフスプ アルファ
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Participants received an intravenous (IV) infusion of M6223 at escalated doses every 2 weeks (Q2W) or every 3 weeks (Q3W) on Day 1 of each Cycle (Each cycle is of 14 days) according to the recommendation of the SMC(Safety Monitoring Committee) until the maximum tolerated dose(MTD) has been reached or confirmed disease progression.
Participants received an IV infusion of M6223 at escalated doses Q2W on Day 1 of each Cycle (Each cycle is of 21 days) according to the recommendation of the SMC until the MTD has been reached or confirmed disease progression.
Participants received an IV infusion of bintrafusp alfa Q2W on Day 1 of each Cycle (Cycle is 14 days) until confirmed disease progression.
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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 |
|---|---|---|
|
Part 1A and 1B: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) Assessed Using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Version 5.0
時間枠：Day 1 to Day 28
|
A DLT is defined as any Grade ≥ 3 non-hematologic AE or any Grade ≥ 4 hematologic AE according to the NCI-CTCAE, occurring during the DLT observation period (28 days from first administration of study intervention) that is not clearly related to the underlying disease or any previous or concomitant medication, concomitant disease or unrelated illness.
A DLT must be confirmed by the Safety Monitoring Committee.
DLT is considered if the following related AEs occur: • Grade ≥ 3 neutropenia with clinical signs/symptoms (e.g., febrile neutropenia).
• Grade ≥ 3 thrombocytopenia with medically concerning bleeding.
• A study intervention-related treatment-emergent AE that in the opinion of the SMC is of potential clinical significance such that further dose escalation would expose participants to unacceptable risk.
• Grade ≥ 3 hematological AE with symptoms that require growth factor support or transfusion to prevent further damage to the participant.
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Day 1 to Day 28
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Part 1A and 1B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs
時間枠：Approximately 2 years 11 months
|
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention or not.
A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important.
TEAEs were defined as events that started or worsened after first dose of study intervention until 30 days after last dose.
TEAEs included both serious and non-serious TEAEs.
Treatment-related TEAEs is defined as reasonably related to the study intervention.
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Approximately 2 years 11 months
|
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Part 1A and 1B: Number of Participants With TEAES With Severity of Grade Greater or Equal to 3 and TEAEs Leading to Deaths
時間枠：Approximately 2 years 11 months
|
An adverse event (AE) is any untoward medical occurrence in a participant temporally associated with the use of the study intervention, regardless of causality.
A serious AE results in death, is life-threatening, requires/prolongs hospitalization, causes disability/incapacity, leads to a congenital anomaly/birth defect, or is otherwise medically significant.
Treatment-emergent adverse events (TEAEs) are those that begin or worsen after the first dose through 30 days post-treatment, and include both serious and non-serious events.
Treatment-related TEAEs are those reasonably related to the study intervention.
Severity is graded per CTCAE v24.1:
Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe/medically significant), Grade 4 (life-threatening/disabling), Grade 5 (death related to AE).
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Approximately 2 years 11 months
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Part 1A and 1B: Number of Participants With Clinically Meaningful Change From Baseline in Laboratory Values
時間枠：Approximately 2 years 11 months
|
Number of participants with clinically meaningful change from baseline in laboratory parameters were reported.
Clinically meaningful abnormalities (identified as laboratory values having CTCAE grades >= 3).
Laboratory investigation included hematology, biochemistry, urinalysis, and coagulation.
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Approximately 2 years 11 months
|
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Part 1A and 1B: Number of Participants With Clinically Meaningful Change From Baseline in Electrocardiogram (ECG)
時間枠：Approximately 2 years 11 months
|
Number of participants with clinically significant change from baseline in ECG parameters were reported.
Clinical Significance was decided by the investigator.
The 12-lead ECGs were recorded after the participants have rested for at least 5 minutes in supine position.
The parameters included heart rate (HR), Respiratory Rate, Pulse Rate, QRS, QT and QTcB calculated by the Bazett formula.
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Approximately 2 years 11 months
|
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Part 1A and 1B: Number of Participants With Clinically Relevant Changes From Baseline in Vital Signs
時間枠：Approximately 2 years 11 months
|
Vital signs included oral body temperature, systolic blood pressure, diastolic blood pressure, and pulse rate.
Clinical Relevance was decided by the investigator.
Number of participants with clinically relevant change from baseline in vital signs were reported.
Clinical relevance was defined as increase more than equal to (>=) 3° temperature, >40 beats heart rate increase, >40 mmHG increase in systolic or diastolic blood pressure, >10 breaths in respiratory rate increase.
|
Approximately 2 years 11 months
|
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Part 1A and 1B: Number of Participants With Worsened Post Baseline Shift in Eastern Cooperative Oncology Group Performance Status
時間枠：Approximately 2 years 11 months
|
The number of participants who experienced worse post baseline shift were assessed as per ECOG performance status score recorded during the treatment.
The ECOG score is categorized as Grade 0, 1, 2, 3 and 4 where Grade 0=fully active, Grade 1=restricted in physically strenuous activity, Grade 2=unable to carry out any work activities, Grade 3=capable of only limited self-care and Grade 4=completely disabled.
|
Approximately 2 years 11 months
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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 |
|---|---|---|
|
Part 1A and Part 1B: Area Under the Serum Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of M6223
時間枠：Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
|
Area under the serum concentration-time curve from time zero to the last sampling time at which the concentration is at or above lower limit of quantification (LLQ).
AUC0-t was calculated according to the mixed log linear trapezoidal rule.
The full form of unit of measure h*mcg/mL is hours · micrograms per milliliter.
|
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
|
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Part 1A and Part 1B: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC 0-inf) of M6223
時間枠：Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
|
Area under the serum concentration time curve from time zero to infinity, calculated as AUC0 t + AUCextra.
AUCextra represents an extrapolated value obtained by Clast/λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured serum concentration is at or above LLQ and λz is elimination rate constant.
|
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
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Part 1A and Part 1B: Area Under Serum Concentration-Time Curve Over a Dosing Interval From Time Zero to Tau (AUC-tau) of M6223
時間枠：Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycle 1 (Cycle is of 21 days in Q3W regimen)
|
Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval.
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Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycle 1 (Cycle is of 21 days in Q3W regimen)
|
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Part 1A and Part 1B: Maximum Observed Serum Concentration (Cmax) of M6223
時間枠：Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
|
Maximum measured serum concentration, calculated from the serum concentration vs. time profile of the individual participants.
|
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
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Part 1A and Part 1B: Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of M6223
時間枠：Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
|
Ctrough is the concentration prior to study drug administration.
|
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
|
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Part 1A and Part 1B: Time to Reach Maximum Serum Concentration (Tmax) of M6223
時間枠：Cycle 1 and 2: Day 1 (-2h, EOI, 4-6h), Day 2 (25-31h), Day 5 (±1h), Day 8 (±1h); Cycle 3 to end of treatment: Day 1 (-2h pre-dose only)
|
Time taken to reach maximum concentration of M66223 after admistration is reported.
|
Cycle 1 and 2: Day 1 (-2h, EOI, 4-6h), Day 2 (25-31h), Day 5 (±1h), Day 8 (±1h); Cycle 3 to end of treatment: Day 1 (-2h pre-dose only)
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Part 1A and Part 1B: Apparent Terminal Half-Life (t1/2) of M6223
時間枠：Cycle 1 and 2: Day 1 (-2h, EOI, 4-6h), Day 2 (25-31h), Day 5 (±1h), Day 8 (±1h); Cycle 3 to end of treatment: Day 1 (-2h pre-dose only)
|
Terminal half-life is the time measured for the concentration to decrease by one half.
Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/ λz, where 'λz' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
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Cycle 1 and 2: Day 1 (-2h, EOI, 4-6h), Day 2 (25-31h), Day 5 (±1h), Day 8 (±1h); Cycle 3 to end of treatment: Day 1 (-2h pre-dose only)
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Part 1A and Part 1B: Elimination Rate Constant (Lambda z) of M6223
時間枠：Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
|
Elimination rate constant was obtained from linear regression of the terminal phase of the log transformed concentration-time data.
|
Pre-dose up to 14 days (in Q2W regimen) or 21 days (in Q3W regimen) post-dose of Cycles 1, 2, and 4 (Each cycle is of 14 days in Q2W regimen and each Cycle is of 21 days in Q3W regimen)
|
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Part 1B: Maximum Observed Serum Concentration (Cmax) of Bintrafusp Alfa
時間枠：Day 1 of Treatment of Cycles 1 and 4 from time zero to 14 days postdose
|
Maximum measured serum concentration, calculated from the serum concentration vs. time profile of the individual participants.
|
Day 1 of Treatment of Cycles 1 and 4 from time zero to 14 days postdose
|
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Part 1B: Serum Concentration Observed Immediately Before Next Dosing (Ctrough) of Bintrafusp Alfa
時間枠：Day 1 of Treatment of Cycles 1 and 4 from time zero to 14 days postdose
|
Ctrough is the concentration prior to study drug administration.
|
Day 1 of Treatment of Cycles 1 and 4 from time zero to 14 days postdose
|
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Part IA and 1B: Number of Participants With Positive Antidrug Antibody (ADA) Assays
時間枠：Pre-dose of Day 1 Cycle 1 (Each Cycle is of 14 days in Q2W regimen and 21 days in Q3W regimen) up to end of safety follow-up visit ( approximately 2 years 11 months)
|
Serum samples were analyzed by a validated assay method to detect the presence of antidrug antibodies (ADA).
Number of participants with positive ADA were reported.
|
Pre-dose of Day 1 Cycle 1 (Each Cycle is of 14 days in Q2W regimen and 21 days in Q3W regimen) up to end of safety follow-up visit ( approximately 2 years 11 months)
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Part 1A and IB: Best Overall Response According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
時間枠：From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months)
|
The ORR is defined as the number of participants with a documented BOR (complete response (CR) or partial response (PR)) by the investigator during treatment with avelumab plus axitinib as firstline therapy.
The BOR is defined as the best tumor response recorded during the observation period.
The definitions of tumor responses are as follows: Complete or PR as the best adjudication result (CR > PR > stable disease [SD] > progressive disease [PD], not Evaluable [NE]) complies with the RECIST tumor assessment guidelines as closely as possible in clinical practice.
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From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months)
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Part 1A and 1B: Duration of Response (DOR) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
時間枠：From first study drug administration until documented disease progression or death due to any cause whichever occurs first( approximately 2 years 11 months)
|
DOR was defined for participants with a confirmed objective response as the time from first documentation of a confirmed objective response (CR or PR) according to RECIST 1.1 to the date of first documentation of objective PD or death due to any cause, whichever occurs first.
CR: Disappearance of all evidence of target and non-target lesions.
PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions.
PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
DOR was determined according to RECIST v1.1 and assessed by IRC.
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From first study drug administration until documented disease progression or death due to any cause whichever occurs first( approximately 2 years 11 months)
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Part 1A and 1B: Time to Tumor Response (TTR) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
時間枠：From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months))
|
TTR was defined for participants who achieved objective response as time from first study drug administration to first documentation of objective tumor response (CR or PR) that was subsequently confirmed.
CR was defined as a score of 1 (no uptake above background), 2 (uptake <= mediastinum), or 3 (uptake <mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow.
PR was defined as >=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease.
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From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months))
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Part 1A and 1B: Disease Control According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
時間枠：From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months))
|
Disease control rate was defined as percentage of participants with disease control.
Disease Control (DC) was defined as the best overall response of CR, PR, or stable disease (SD).
CR: score of 1 (no uptake above background), 2 (uptake <= mediastinum), or 3 (uptake less than <mediastinum but <=liver) with or without a residual mass on Positron Emission Tomography 5-Point Scale, for lymph nodes and extra lymphatic sites; no new lesions; no evidence of fluorodeoxyglucose -avid disease in bone marrow.
PR: >=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >=50% decrease in Sum of the Products of Diameters of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease.
SD: <50% decrease in SDP of up to 6 dominant, measurable nodes and extranodal sites; no criteria for progressive disease met.
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From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months))
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Part 1A and 1B: Progression-free Survival Time According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed as Per Investigator
時間枠：From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months)
|
Progression Free Survival (PFS) time is defined as the time from start date of treatment to the date of the first documentation of objective progression of disease (PD) or death due to any cause, whichever occurs first.
The tumor response will be determined according to RECIST 1.1 and assessed by the investigator.
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From first study drug administration until documented disease progression or death due to any cause whichever occurs first (approximately 2 years 11 months)
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Part 1A and 1B: Overall Survival
時間枠：From first study drug administration to the date of death due to any cause (approximately 2 years 11 months)
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Overall survival was defined as the time (in months) from first study drug administration to the date of death due to any cause.
Participants last known to be alive were censored at date of last contact.
Analysis was performed using Kaplan-Meier method.
|
From first study drug administration to the date of death due to any cause (approximately 2 years 11 months)
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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。
捜査官
- スタディディレクター：Medical Responsible、Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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)
2020年7月10日
一次修了 (実際)
2023年6月23日
研究の完了 (実際)
2023年6月23日
試験登録日
最初に提出
2020年6月30日
QC基準を満たした最初の提出物
2020年6月30日
最初の投稿 (実際)
2020年7月7日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月4日
QC基準を満たした最後の更新が送信されました
2026年4月13日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
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
IPD プランの説明
私たちは、臨床試験データの責任ある共有を通じて、公衆衛生の向上に取り組んでいます。
米国と欧州連合の両方で新製品または承認された製品の新しい適応症が承認された後、研究スポンサーおよび/またはその関連会社は、研究プロトコル、匿名化された患者データと研究レベルのデータ、および編集された臨床研究レポートを共有します。正当な研究を実施するために必要な場合、要求に応じて、資格のある科学および医学研究者と。
データを要求する方法の詳細については、当社の Web サイト bit.ly/IPD21 を参照してください。
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
はい
米国FDA規制機器製品の研究
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。