December 2024 SCRI Release Copied
SCRI Trials and Trial Regimen Updates
The following updates were completed between Nov. 15, 2024, and Dec. 12, 2024. Sarah Cannon Research Institute now manages all SCRI/USOR trials and trial regimens. For questions about these trials and regimens, please contact SCRIiKMEMRedits@McKesson.com.
New Builds Completed
| Study Number | Notes for New Build |
| 23190 | USOR 23190 GYN 124 Phase 3 Arm 1 MK-2870 Q14D
USOR 23190 GYN 124 Phase 3 Arm 2 Doxorubicin Q21D USOR 23190 GYN 124 Phase 3 Arm 2 Paclitaxel D1,8,15 Q28D |
| 24106 | USOR 24106 MM 136 Phase 3 Stage 2 Arm A Iberdomide + Daratumumab + Dexamethasone Q28D
USOR 24106 MM 136 Phase 3 Stage 2 Arm B Daratumumab + Bortezomib + Dexamethasone Q21D (C1-8) USOR 24106 MM 136 Phase 3 Stage 2 Arm B Daratumumab Q28D (C9+) |
| 24099 | USOR 24099 ALL09 Phase 1 Dexamethasone D-7 to Day –1
USOR 24099 ALL09 Phase 1 VNX-101 + Dexamethasone D0+ |
| 23294 | USOR 23294 | GYN 132 Ph3 Arm 2 Gemcitabine D1,8 Q21D
USOR 23294 | GYN 132 Ph3 Arm 2 Irinotecan D1,8,15,22 Q42D USOR 23294 | GYN 132 Ph3 Arm 2 Pemetrexed Q21D USOR 23294 | GYN 132 Ph3 Arm 2 Tisotumab Vedotin Q21D USOR 23294 | GYN 132 Ph3 Arm 2 Topotecan D1-5 Q21D USOR 23294 | GYN 132 Ph3 Arm 2 Vinorelbine D1,8 Q21D USOR 23294 | GYN 132 Ph3 Run-in AND Arm 1 MK-2870 Q14D |
| 22320 | USOR 22320 BRE 441 Phase 3 Arm 1 Dato-DXd + Durvalumab Q21D
USOR 22320 BRE 441 Phase 3 Arm 2 Pembrolizumab + Gemcitabine + Carboplatin Q21D USOR 22320 BRE 441 Phase 3 Arm 2 Pembrolizumab + Nab-Paclitaxel Q21D USOR 22320 BRE 441 Phase 3 Arm 2 Pembrolizumab + Paclitaxel Q21D |
Updated Reference Information
| Study Number | Updated Reference Information | Updated Drug Service Order Information | Updated Regimen Instructions | Other Changes |
| 23025 | Version 8.0: 06 September 2024. | Updated Drug dose and dosing schedule comments | NA | NA |
| 23189 | NA | Updated reconstitution instructions | Added dosing weight instructions | Updated infusion time in IP instructions |
| 23288 | NA | Updated preparation/administration instructions | Updated cohort-specific dosing instructions | NA |
| 23076 | NA | Updated order of drugs administered. Rearranged drug items under corresponding headers. Added hydration | Updated order of administration comment. Added weight-based dosing | NA |
| 23276 | Amendment 2.0: 24 June 2024 | NA | NA | NA |
| 21462 | Version 6.0: 02 Aug 2024 | NA | NA | Updated cycle length to include an additional administration day |
| 20403 | Protocol Amendment 5 Version 6.0: 25 April 2024 | NA | NA | NA |
| 22042 | Amendment 4: 30 MAY 2024 | Removed twice daily IP line. | Removed fasting requirement. Added administration instruction. | Added 7 new regimens |
| 23095 | Version 4.0: 26 September 2024 | Added “Supplied by sponsor” | Adding wording on prophylaxis, observation, double-blind, | Activated 2 new arms |
| 23185 | NA | Updated reconstitution instructions | NA | NA |
| 23332 | Added Protocol Clarification Memo #2: 14 Oct 2024 | Updated reconstitution instructions | Added administration wording | Combined 2 dose builds into 1 build with 2 dose options. Added additional form of administration for AZA (SQ & IV) |
| 21533 | NA | Removed Ondansetron premedication | NA | Updated diagnosis code |
| 22302 | NA | Added additional form of administration, clarified form reconstitutions
|
Clarified dose formulation choices | Inactivated closed arm |
| 20408 | Protocol Substudy Version 2: 25 August 2023
Protocol Version 5: 25 August 2023 |
NA | NA | New arm |
| 22002 | NA | NA | NA | Inactivated closed arm |
| 22244 | NA | NA | NA | New arm |