May 2025 SCRI Release Copied
SCRI Trials and Trial Regimen Updates
The following updates were completed between April 18, 2025, through May 16, 2025. 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 |
| 24119 | USOR 24119 LUN 568 Phase 2 Dose Optimization Part 1 AMG 193 Q28D |
| 24114 | USOR 24114 GU 247 Phase 3 Control Arm Abiraterone Acetate + Prednisone Q30D
USOR 24114 GU 247 Phase 3 Control Arm Cabazitaxel + Prednisone Q21D USOR 24114 GU 247 Phase 3 Control Arm Enzalutamide Q30D USOR 24114 GU 247 Phase 3 Experimental Arm Xaluritamig Q28D |
| 24208 | USOR 24208 BRE 449 Phase 2 Part 2 Arm A Pembrolizumab + HER3-DXd fb Pembrolizumab + Paclitaxel + Carboplatin Q21D
USOR 24208 BRE 449 Phase 2 Part 2 Arm B Pembrolizumab + Paclitaxel + Carboplatin fb Pembrolizumab + HER3-DXd Q21D USOR 24208 BRE 449 Phase 2 Part 2 Arm C Pembrolizumab + Paclitaxel + Carboplatin fb Pembrolizumab + Doxorubicin or Epirubicin + Cyclophosphamide Q21D USOR 24208 BRE 449 Phase 2 Pembrolizumab +/- Capecitabine (Cycle 9+) Q42D USOR 24208 BRE 449 Phase 2 Pembrolizumab +/- Doxorubicin or Epirubicin + Cyclophosphamide (Q2W) Q42D (Cycle 9+) USOR 24208 BRE 449 Phase 2 Pembrolizumab +/- Doxorubicin or Epirubicin + Cyclophosphamide (Q3W) Q42D (Cycle 9+) USOR 24208 BRE 449 Phase 2 Pembrolizumab +/- Olaparib (Cycle 9+) Q42D USOR 24208 BRE 449 Phase 2 Part 1 Safety Lead-in Pembrolizumab + HER3- DXd fb Pembrolizumab + Paclitaxel + Carboplatin Q21D |
| 24207 | USOR 24207 GU 248 Phase 2 Arm 1 Livmoniplimab + Budigalimab Q21D
USOR 24207 GU 248 Phase 2 Arm 2 Livmoniplimab + Budigalimab Q21D USOR 24207 GU 248 Phase 2 Arm 3 Docetaxel Q21D USOR 24207 GU 248 Phase 2 Arm 3 Gemcitabine D1,8 Q21D USOR 24207 GU 248 Phase 2 Arm 3 Paclitaxel Q21D |
| 24043 | USOR 24043 GU 245 Phase 2 PET Imaging Agents AAA517 or Piflufolastat (18F)
USOR 24043 GU 245 Phase 2 Arm B Lutetium (177Lu) vipivotide tetraxetan (AAA617) + ARPI Q42D USOR 24043 GU 245 Phase 2 Arm A Lutetium (177Lu) vipivotide tetraxetan (AAA617) Q42D |
| 24126 | USOR 24126 RM 858 Phase 2 BDTX-1535 Q21D |
| 24153 | USOR 24153 GI 382 Phase 3 Double-Blind Quemliclustsat or Placebo + Nab- Paclitaxel + Gemcitabine Q28D |
| 24189 | USOR 24189 LUN 579 Phase 2b Cohort 2 Amivantamab SC + Carboplatin + Pemetrexed Q21D
USOR 24189 LUN 579 Phase 2b Cohort 1 Amivantamab SC + Lazertinib Q28D |
| 24157 | USOR 24157 MEL 75 Phase 3 Crossover (Arm B) NMA-LD + Lifileucel (off-site documentation) Q10D
USOR 24157 MEL 75 Phase 3 Arm B Pembrolizumab (Initial) D5,26 USOR 24157 MEL 75 Phase 3 Arm A Pembrolizumab + NMA-LD + Lifileucel (off- site documentation) Q37D USOR 24157 MEL 75 Phase 3 All Arms Pembrolizumab Maintenance Q42D |
| 24215 | USOR 24215 LUN 578 Phase 2 Telisotuzumab Vedotin Q14D |
| 23254 | USOR 23254 MM 186 Phase 3 Arm B Pomalidomide + Bortezomib + Dexamethasone (PVd) Q21D
USOR 23254 MM 186 Phase 3 Arm B Elotuzumab + Pomalidomide + Dexamethasone (EPd) Q28D USOR 23254 MM 186 Phase 3 Arm B Carfilzomib + Dexamethasone (Kd) Q28D USOR 23254 MM 186 Phase 3 Arm A Elranatamab Q28D |
| 24098 | USOR 24098 GI 386 Phase 3 Arm B Cetuximab D1,8,15,22 + FOLFIRI Q28D USOR 24098 GI 386 Phase 3 Arm B Cetuximab D1,15 + FOLFIRI Q28D
USOR 24098 GI 386 Phase 3 Arm B Bevacizumab + FOLFIRI Q28D USOR 24098 GI 386 Phase 3 Arm A Amivantamab + FOLFIRI Q28D |
| 24239 | USOR 24239 CLL 63 Phase 2 Arm B Zanubrutinib Q28D
USOR 24239 CLL 63 Phase 2 Arm A Zanubrutinib fb Zanubrutinib + Sonrotoclax Q28D |
| 24025 | USOR 24025 MULTI 91 Phase 1b/2 Safety Run-In Ifinatamab Deruxtecan (I- DXd) Q21D (HCC)
USOR 24025 MULTI 91 Phase 1b/2 Ifinatamab Deruxtecan (I-DXd) Q21D |
| 22118 | USOR 22118 LUN 552 Phase 3 Sotorasib + Pemetrexed + Carboplatin Q21D
USOR 22118 LUN 552 Phase 3 Pembrolizumab + Pemetrexed + Carboplatin Q21D |
Updated Reference Information
| Study Number | Updated Reference Information | Updated Regimen Instructions | Other Changes |
| 23340 | N/A | N/A | Added stability & drug instruction |
| 22181 | Master Amendment 5: 14 Nov 2024 | N/A | Updated drug instruction |
| 22252 | Master Amendment 3: 25 Jun 2024 | N/A | N/A |
| 23283 | N/A | N/A | Updated cycling |
| 21320 | Amendment 9 Version 10 | N/A | Added phase 2b arms |
| 2335 | Amendment 1.0: 23 Feb 2025 | N/A | Set IP dose |
| 23031 | Amendment 5: 09 Apr 2025 | N/A | Updated weight calculation instructions |
| 24077 | N/A | N/A | Updated flush requirements |
| 22201 | N/A | N/A | Updated premedications |
| 23172 | N/A | N/A | Updated drug procurement and arms |
| 22101 | Amendment e: 31 Jan 2025. | N/A | Updated cycling |
| 24010 | Amendment v3: 12 Mar 2025 | N/A | N/A |
| 22037 | Amendment v10 18 Nov 2025 | Added premed instructions | Updated drug name, added premeds |
| 24050 | Amendment 4.0 28 Mar 2024 | N/A | Updated IP arm to off- site documentation |
| 23180 | Amendment v2 17 Jan 2025 | Updated observation comments | N/A |
| 23269 | Amendment v5.0 26 Nov 2024 | Premedication clarification | Unchecked all premeds for SOC drugs |
| 20186 | Amendment v7 19 Feb 2025 | N/A | Added Entrectinib drug admin instruction |
| 23087 | Amendment 3 21 Feb 2025 | Updated observation wording | Added new form SQ to SOC drugs, added weight and stability instruction |