Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as R-DXd, DS-6000a, Raludotatug Deruxtecan (R-DXd), MK-5909
Raludotatug Deruxtecan · 9 trials · 13 indications
PFS is defined as the time from randomization to the first documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered disease progression. PFS as assessed by blinded independent central review (BICR) will be presented.
OS is defined as the time from randomization to death due to any cause.
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) as assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR will be assessed by Blinded Independent Central Review (BICR). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants who experience an AE will be reported.
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The percentage of participants who discontinue study intervention due to an AE will be reported.
Objective response rate (ORR) is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1 criteria.
Disease control rate (DCR) is defined as proportion of participants who achieved a BOR of confirmed CR, confirmed PR, or stable disease (maintained for ≥5 weeks) according to RECIST version 1.1.
The ORR was defined as the percentage of participants with confirmed Complete Response (CR) or Partial Response (PR), by BICR assessment based on RECIST version 1.1.
PFS is defined as the time from the date of randomization to the date of disease progression, defined as the first documented radiological progression or death due to any cause, whichever comes first.
DLTs are defined as toxicities during the DLT evaluation period that are assessed by the investigator to be possibly, probably, or definitely related to study treatment and include: Grade 4 thrombocytopenia of any duration or Grade 3 thrombocytopenia lasting ≥7 days; Grade 3 or higher thrombocytopenia associated with clinically significant bleeding; Grade 4 lymphocytopenia lasting ≥14 days; Grade 4 anemia of any duration; any other Grade 4 hematologic toxicity lasting ≥7 days; febrile neutropenia Grade 3 or Grade 4 meeting pre-specifications; pre-specified hepatic organ toxicities; all Grade 3 or higher other nonhematologic toxicities except those pre-specified; other pre-specified nonhematologic toxicities; any delay in treatment with the planned dose of ≥21 days or discontinuation of treatment due to a toxicity during the DLT evaluation period, or Grade 5 toxicity. The number of participants with DLTs will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with one or more AEs will be reported.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
ORR is defined as the proportion of participants with best overall response (BOR) of complete response (CR) or partial response (PR).
| Arm | Type | Description |
|---|---|---|
| R-DXd +/- Bevacizumab | EXPERIMENTAL | Participants will receive intravenous (IV) raludotatug deruxtecan (R-DXd) with or without IV bevacizumab for up to 2 years until progressive disease (PD), unacceptable toxicity, or other protocol-specified reason for discontinuation |
| Standard of Care | ACTIVE_COMPARATOR | Participants receive 6 to 8 cycles of investigator's choice of one of three options of platinum-based chemotherapy with or without IV bevacizumab. Bevacizumab treatment if elected, will continue until PD, unacceptable toxicity, or other protocol specified reason for discontinuation |
| Arm 1: R-DXd with or without bevacizumab | EXPERIMENTAL | Participants will receive intravenous (IV) raludotatug deruxtecan (R-DXd)with or without IV bevacizumab for up to 2 years until progressive disease (PD), unacceptable toxicity, or other protocol-specified reason for discontinuation. |
| Arm 2: Standard of care (bevacizumab or observation only) | ACTIVE_COMPARATOR | Participants will receive bevacizumab 15 mg/kg IV q3w for up to 22 cycles (each cycle=21 days) until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention or will be observed and actively followed if not receiving bevacizumab. |
| Arm 1: Raludotatug deruxtecan (R-DXD) | EXPERIMENTAL | Participants receive 5.6 mg/kg of R-DXD, every 3 weeks (Q3W) (Day 1 of every 21-day cycle) via intravenous (IV) infusion until progressive disease (PD) or discontinuation. |
| Arm 2: Infinatamab deruxtecan (I-DXD) High Dose | EXPERIMENTAL | Participants receive 12 mg/kg of I-DXD, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation. |
| Arm 3: I-DXD Low Dose | EXPERIMENTAL | Participants receive 8 mg/kg of I-DXD, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation. |
| Arm 4: Docetaxel | ACTIVE_COMPARATOR | Participants receive 75 mg/m\^2 of Docetaxel, Q3W (Day 1 of every 21-day cycle) via IV infusion until PD or discontinuation. |
| Raludotatug Deruxtecan | EXPERIMENTAL | Participants receive raludotatug deruxtecan (R-DXd) 5.6 mg/kg via intravenous (IV) Infusion every 3 weeks (q3w) until disease progression or discontinuation criterion is met. |
| Ifinatamab Deruxtecan | EXPERIMENTAL | Participants receive ifinatamab deruxtecan (I-DXd) 12 mg/kg via IV infusion q3w until disease progression or discontinuation criterion is met. |
| Docetetaxel | ACTIVE_COMPARATOR | Participants receive docetaxel 75mg/m2 via IV infusion q3w until disease progression or discontinuation criterion is met. |
| Raludotatug Deruxtecan (R-DXd) | EXPERIMENTAL | R-DXd will be administered via IV infusion. |
| Endometrial Cancer Cohort | EXPERIMENTAL | Participants with endometrial cancer who will receive raludotatug deruxtecan (R-DXd) administered intravenously every 3 weeks (Q3W). |
| Cervical Cancer Cohort | EXPERIMENTAL | Participants with cervical cancer who will receive R-DXd administered intravenously Q3W. |
| Non-high-grade Serous Ovarian Cancer | EXPERIMENTAL | Participants with non-high-grade serous ovarian cancer who will receive R-DXd administered intravenously Q3W. |
| Urothelial Cancer Cohort | EXPERIMENTAL | Participants with urothelial cancer who will receive R-DXd administered intravenously Q3W. |
| Clear Cell Renal Carcinoma (ccRCC) Cohort | EXPERIMENTAL | Participants with clear cell renal carcinoma (ccRCC) who will receive R-DXd administered intravenously Q3W. |
| Part A: R-DXd 4.8mg/kg Q3W | EXPERIMENTAL | Participants will be randomized to receive intravenous R-DXd administered at a dose of 4.8 mg/kg every 3 weeks (Q3W). |
| Part A: R-DXd 5.6 mg/kg Q3W | EXPERIMENTAL | Participants will be randomized to receive intravenous R-DXd administered at a dose of 5.6 mg/kg every 3 weeks (Q3W). |
| Part A: R-DXd 6.4 mg/kg Q3W | EXPERIMENTAL | Participants will be randomized to receive intravenous R-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W). |
| Part B: R-DXd RP3D Q3W | EXPERIMENTAL | Participants will be randomized to receive intravenous R-DXd administered at the Recommended Phase 3 Dose (RP3D) every 3 weeks (Q3W). |
| Part B: Investigator's Choice | ACTIVE_COMPARATOR | Participants will be randomized to receive intravenous treatment with investigator's choice of paclitaxel, pegylated liposomal doxorubicin (PLD), or topotecan. |
| Cohort A-1 Arm 1 (R-DXd + Carboplatin Dose 1) | EXPERIMENTAL | Participants receive escalating doses of intravenous (IV) raludotatug deruxtecan (R-DXd) in combination with carboplatin at Dose 1. Participants can receive up to a maximum of six 3-week cycles of carboplatin (approximately 4 months) and will receive raludotatug deruxtecan until disease progression or discontinuation. |
| Cohort A-1 Arm 2 (R-DXd + Paclitaxel) | EXPERIMENTAL | Participants receive escalating doses of IV R-DXd in combination with paclitaxel. Participants can receive up to a maximum of six 3-week cycles of paclitaxel (approximately 4 months) and will receive R-DXd until disease progression or discontinuation. |
| Cohort A-1 Arm 3 (R-DXd + Carboplatin Dose 2) | EXPERIMENTAL | Participants receive escalating doses of intravenous (IV) R-DXd in combination with carboplatin at Dose 2. Participants can receive up to a maximum of six 3-week cycles of carboplatin (approximately 4 months) and will receive R-DXd until disease progression or discontinuation. |
| Cohort B-1 (R-DXd + Bevacizumab) | EXPERIMENTAL | Participants receive escalating doses of IV R-DXd in combination with bevacizumab until disease progression or discontinuation. |
| Cohort B-2 (R-DXd RP2D + Bevacizumab) | EXPERIMENTAL | Participants with platinum-resistant recurrent ovarian cancer (PRROC) receive recommended Phase 2 dose (RP2D) of IV R-DXd in combination with bevacizumab until disease progression or discontinuation. |
| Cohort C-1 (R-DXd + Pembrolizumab) | EXPERIMENTAL | Participants receive escalating doses of IV R-DXd in combination with pembrolizumab. Participants can receive up to a maximum of thirty-five 3-week cycles of pembrolizumab (approximately 2 years) and will receive R-DXd until disease progression or discontinuation. |
| Cohort D (R-DXd +/- Bevacizumab) | EXPERIMENTAL | Participants with platinum-sensitive recurrent ovarian cancer (PSROC) receive IV R-DXd in combination with or without bevacizumab until disease progression or discontinuation. |
| Cohort A-2 Arm 1 (R-DXd RP2D + Carboplatin +/- Bevacizumab) | EXPERIMENTAL | Participants with PSROC will receive the RP2D of R-DXd in combination with a maximum of 6 cycles of carboplatin with or without bevacizumab, until disease progression or discontinuation. |
| Cohort A-2 Arm 2 (R-DXd RP2D + Paclitaxel +/- Bevacizumab) | EXPERIMENTAL | Participants with PSROC will receive the RP2D of R-DXd in combination with a maximum of 6 cycles of paclitaxel with or without bevacizumab, until disease progression or discontinuation. |
| Cohort A-2 Arm 3 (Platinum-Based Doublet Chemotherapy +/- Bevacizumab) | ACTIVE_COMPARATOR | Participants with PSROC will receive one of 3 regimens of investigator's choice of platinum-based doublet chemotherapy with or without bevacizumab. Platinum-based doublet chemotherapy will be administered for maximum of 8 cycles. Bevacizumab can be administered until disease progression or discontinuation. |
| Cohort E-1 (R-DXd + MK-2010) | EXPERIMENTAL | Participants receive escalating doses of IV R-DXd in combination with MK-2010. Participants can receive up to a maximum of thirty-five 3-week cycles of MK-2010 (approximately 2 years) and will receive R-DXd until disease progression or discontinuation. |
| Cohort C-2 Arm 1 (Carboplatin + Paclitaxel + Pembrolizumab → R-DXd + Pembrolizumab) | EXPERIMENTAL | Participants will receive carboplatin (Dose 1 or Dose 2), paclitaxel (five 3-week cycles), and pembrolizumab during the induction phase. During the maintenance phase, participants will receive RP2D of IV R-DXd (up to 2 years; participants with PR or SD at 2 years may continue until disease progression) in combination with pembrolizumab (up to thirty-five 3-week cycles). |
| Cohort C-2 Arm 2 (Carboplatin + Paclitaxel) | EXPERIMENTAL | Participants will receive carboplatin (Dose 1 or Dose 2) and paclitaxel (seven 3-week cycles), followed by standard of care observation. |
| Cohort C-2 Arm 3 (R-DXd + Pembrolizumab + Bevacizumab) | EXPERIMENTAL | Participants with PSROC will receive RP2D of R-DXd in combination with pembrolizumab (up to thirty-five 3-week cycles) and bevacizumab until progressive disease. |
| Dose Escalation | EXPERIMENTAL | Participants with ovarian cancer (OVC) or renal cell carcinoma (RCC) will receive an intravenous infusion of R-DXd (starting dose 1.6 mg/kg). |
| Dose Expansion: Cohort B-1 | EXPERIMENTAL | Participants with RCC will receive an intravenous infusion of R-DXd at the RDE. Enrollment has ended for this cohort. |
| Dose Expansion: Cohort B-2 | EXPERIMENTAL | Participants with OVC will receive an intravenous infusion of R-DXd at the RDE. |
| Name | Type | Description |
|---|---|---|
| R-DXd | BIOLOGICAL | R-DXd alone or in combination with bevacizumab administered via IV infusion |
| Bevacizumab | DRUG | Bevacizumab 10 or 15 mg/kg administered via IV infusion on day 1 q3w |
| Carboplatin | DRUG | Carboplatin area under the curve (AUC) 5 mg/mL\*min or AUC 4 mg/mL\*min administered on day 1 q3w for a maximum of 8 cycles |
| Paclitaxel | DRUG | Paclitaxel 175 mg/m\^2 administered via IV infusion on day 1 q3w for a maximum of 8 cycles |
| Gemcitabine | DRUG | Gemcitabine 1000 mg/mL administered via IV infusion on day 1 and day 8 of each 3-week cycle for a maximum of 8 cycles |
| Pegylated liposomal doxorubicin (PLD) | DRUG | PLD 30 mg/m\^2 administered via IV infusion on day 1 of each 4-week cycles for a maximum of 8 cycles |
| I-DXD | BIOLOGICAL | IV Infusion |
| Docetaxel | DRUG | IV Infusion |
| Rescue Medications | DRUG | Participants receive rescue medications consisting of a combination regimen to include corticosteroids with a 5-hydroxytryptamine subtype 3 receptor antagonist and/or a neurokinin-1 receptor antagonist, all per approved product label and following institutional standards or local guidelines. |
| Rescue Medication | DRUG | Participants are premedicated with corticosteroids per approved product label and following institutional standards or local guidelines. |
| Raludotatug Deruxtecan | BIOLOGICAL | IV Infusion |
| Ifinatamab Deruxtecan | BIOLOGICAL | IV Infusion |
| Docetetaxel | DRUG | IV Infusion |
| 5-hydroxytryptamine subtype 3 receptor antagonist | DRUG | Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion |
| Neurokinin-1 receptor antagonist | DRUG | Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion |
| Corticosteroid | DRUG | Administered as a rescue medication per approved product label before R-DXd or I-DXd infusion, and for 3 days starting 1 day prior to docetaxel administration |
| Raludotatug Deruxtecan (R-DXd) | BIOLOGICAL | Administered via intravenous (IV) infusion. |
| Topotecan | DRUG | Topotecan will be administered as an IV infusion |
| PLD | DRUG | PLD will be administered as an IV infusion |
| Pembrolizumab | BIOLOGICAL | IV infusion on Day 1 of every 3-week cycle for a maximum of 35 cycles. |
| Pegylated liposomal doxorubicin | DRUG | IV injection administered on Day 1 of each 4-week cycle |
| MK-2010 | DRUG | IV infusion on Day 1 of every 3-week cycle |
| DS-6000a | DRUG | Intravenous administration at doses starting at 1.6 mg/kg on Day 1 of Cycle 1 |
The main inclusion criteria include but are not limited to the following: * Has a histologically or cytologically documented advanced high-grade serous or high-grade endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer. * Has received 1 line of platinum-based therapy with a...
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Raludotatug Deruxtecan is an investigational antibody-drug conjugate developed by Merck & Company, Inc. (MRK) for oncology. It is being studied in advanced solid tumors, including ovarian cancer, gastrointestinal cancer, and non-small-cell lung cancer. It is also known as R-DXd and DS-6000a.
Raludotatug Deruxtecan is being studied for advanced solid tumors, with the largest focus on ovarian cancer, including recurrent ovarian cancer and first-line maintenance settings. It is also in development for gastrointestinal cancer and non-small-cell lung cancer. It is investigational and not approved for any use.
Raludotatug Deruxtecan is developed by Merck & Company, Inc., which trades under the ticker MRK. The ovarian cancer studies are run in collaboration with the ENGOT and GOG research networks under the REJOICE-Ovarian program.
Raludotatug Deruxtecan is in Phase 2 development overall, and it is also being evaluated in Phase 3 ovarian cancer trials. It is investigational and has not been approved by the FDA. The program includes two recruiting Phase 3 studies, one Phase 2 study, and one Phase 1 study.
Raludotatug Deruxtecan is in four registered trials. Phase 3 studies include NCT07776691 in non-HRD-positive advanced ovarian cancer and NCT07743164 in ovarian cancer after progression on PARP inhibitors. Phase 2 NCT06864169 enrolls gastrointestinal cancer patients, and Phase 1 NCT06843447 studies recurrent ovarian cancer.
Yes. Raludotatug Deruxtecan is also known as R-DXd, DS-6000a, and R-DXD. These names refer to the same Merck antibody-drug conjugate, so trial records and publications using any of these names describe the same investigational agent.