Altai Protocol Library
1041 protocols and counting
All protocols with references and links
All protocols reviewed by a Medical Oncologist/Hematologist
All protocols in major guidelines included
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New Reference: Trastuzumab deruxtecan in patients with HER2-positive metastatic breast cancer
Study: Phase III, randomized, controlled, multicenter, open-label trial (DESTINY-Breast-02) HER2-positive, previously received trastuzumab-emtansine, unresectable or metastatic breast cancer Trastuzumab-deruxtecan (n=406) vs. SOC (n=202) Efficacy: mPFS: 17.8 vs 6.9 mos, p
New Protocol: Pembrolizumab in combination with gemcitabine and cisplatin for patients with advanced biliary tract cancer
Study: Phase III, double-blind, randomized, controlled, multicenter, open-label trial (KEYNOTE-966) Previously untreated, unresectable, locally advanced or metastatic biliary tract cancer Pembrolizumab + Gemcitabine + Cisplatin (n=533) vs. Gemcitabine + Cisplatin
New Protocol: Ibrutinib and rituximab for patients with previously untreated chronic lymphocytic leukemia (CLL)
Study: Phase III, randomized,controlled, multicenter, open-label trial (FLAIR) Treatment naive CLL–small lymphocytic lymphoma (SLL) İbrutinib + Rituximab (n=386) vs. FCR (n=385) Efficacy: mPFS: NR vs. 67 mos, p
New Protocol: Trifluridine–Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer
Study: Phase III, randomized, open-label trial (SUNLIGHT) Adult patients who had received no more than two previous chemotherapy regimens for the treatment of advanced colorectal cancer Trifluridine–tipiracil (FTD–TPI) + Bevacizumab
New indication: Subcutaneous Rituximab for the First-Line Treatment of Low–Tumor Burden Follicular Lymphoma
Study: Randomized, open-label phase 3 trial (LYSA) Previously untreated low-burden Follicular lymphoma SOC (n=102) vs. Rituximab sc (n=100) Efficacy: CR: 36.3% vs. 59.0%, p=0.001 4-year PFS: 41.2% vs.58.1%, p=0.008 4-year
New indication: Enfortumab Vedotin Plus Pembrolizumab in Previously Untreated Advanced Urothelial Cancer
Study: Multicenter, open-label, phase 1/2 trial Cisplatin ineligible, local advanced/metastatic urothelial carcinoma Enfortumab vedotin + pembrolizumab q21 (n=45) Efficacy: CRR: 15.6% [7 of 45 pts] ORR: 73.3% [33 of 45
New Indication: Pembrolizumab Added to Ifosfamide, Carboplatin, and Etoposide Chemotherapy for Relapsed or Refractory Classic Hodgkin Lymphoma
Study: Multicenter, non-randomized, phase 2trial Relapsed or refractory classic Hodgkin lymphoma Pembrolizumab + ICE (n=37) Efficacy: CRR: 86.5% [32 of 37 pts] ORR: 97.3% [36 of 37 pts] 2-year PFS:
New Indication: Liposomal Irinotecan Plus Fluorouracil and Leucovorin for Patients with Previously Treated Metastatic Biliary Tract Cancer
Study: Multicenter, randomized, open-label phase 2b trial (NIFTY) Advanced biliary tract cancer whose disease progressed while receiving first-line gemcitabine plus cisplatin nal-IRI + FU+LV (n=88) vs. FU+LV (n=86) Efficacy: mPFS:
New Indication: Neoadjuvant–Adjuvant or Adjuvant-Only Pembrolizumab in Advanced Melanoma
Study: Open-label, phase 2 study Treatment naïve resectable sage IIIB-IVC metastatic melanoma (cutaneous, acral, or mucosal) Pembrolizumab: Neoadjuvant x 3 + Adjuvant x 15 doses (n=154) vs. Adjuvant x 18
New Indication: Pembrolizumab plus Chemotherapy in Advanced Endometrial Cancer
Study: Phase III, randomized, double-blind, placebo-controlled Advanced-stage, metastatic, or recurrent endometrial cancer of any histologic subtype except for carcinosarcoma Pembrolizumab + Chemotherapy (n=365) vs. Chemotherapy (n=548) Efficacy: dMMR cohort mPFS:
New Indication: Rucaparib in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Study: Randomized, controlled, phase 3 trial (TRITON-3) Metastatic, castration-resistant prostate cancer with a BRCA1, BRCA2, or ATM alteration and who had disease progression after treatment with a second-generation androgen-receptor pathway
New Protocol: Niraparib and Abiraterone Acetate for Metastatic Castration-Resistant Prostate Cancer (CRPC)
Study: Phase III, randomized, double-blind, placebo-controlled, multicenter (MAGNITUDE) Treatment naïve, Homologous Recombination Repair positive (HRR+) mCRPC Niraparib + Abiraterone acetate + prednizon (Niraparib + AAP group, n=212) vs. PBO +
New Protocol: Axitinib and Avelumab in Patients with Recurrent/Metastatic Adenoid Cystic Carcinoma (ACC)
Study: Open-label, single-arm, phase 2 study Pretreated metastatic or recurrent ACC Axitinib + Avelumab q28 (n=28) Efficacy: ORR: 21% [8.3%-41.0%] mPFS: 7.3 mos [3.7-11.2 mos] mOS: 16.6 mos [12.4-NR] Safety:
New Indication: Trastuzumab Deruxtecan for Human Epidermal Growth Factor Receptor 2–Expressing Advanced or Recurrent Uterine Carcinosarcoma (UCS)
Study: Phase II, multicenter, single-arm study (STATICE) Pretreated advanced or recurrent HER2-expressing UCS Trastuzumab Deruxtecan: her2 1+ (low group, n=10) vs. her2 ≥2+ (high group, n=22) Efficacy: ORR: 68% vs.
New Drug: Retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC)
Study: Open-label, multicenter, single-arm, phase 2 study Treatment naïve metastatic or recurrent locally advanced MCC Retifanlimab q28 (n=65) Efficacy: ORR: 52% [40.0%-65.0%]; cR:18% DOR ≥6 mos: 76% [26 pts of
New drug:Camrelizumab Plus Apatinib in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Study: Open-label, single-arm, phase II trial Refractory to at least one line of systemic chemotherapy NPC Camrelizumab + Apatinib q21 (n=58) Efficacy: ORR: 65% [51.9%-57.5%] mPFS: 10.4 mos [7.2-3.6 mos]
New Indication: Darolutamide Maintenance in Patients with Metastatic Castration-Resistant Prostate Cancer With Nonprogressive Disease After Taxane Treatment (SAKK 08/16)
Study: Randomized , phase 2 trial Patients with mCRPC who received prior androgen-receptor pathway inhibitors (ARPIs) and subsequently had nonprogressive disease on a taxane Darolutamide (n=92) Efficacy: 12 weeks rPFS:
New Protocol: Bortezomib-Dexamethasone, Rituximab, and Cyclophosphamide as First-Line Treatment for Waldenström’s Macroglobulinemia
Study: Prospectively Randomized , phase 3 trial Treatment naïve Waldenström’s macroglobulinemia (WM) Bortezomib, dexamethasone, rituximab, and cyclophosphamide (B-DRC ) vs. DRC Efficacy: 24 mos PFS: 80.6 vs 72.8 %, p=0.320
New indication: Encorafenib Plus Binimetinib and Cetuximab in Previously Untreated BRAFV600E-Mutant Metastatic Colorectal Cancer (ANCHOR)
Study: Single-arm, multicenter, Phase-2 trial Previosly untreated, BRAF V600E mutant CRC Encorafenib + Binimetinib + Cetuximab q28 (n=95) Efficacy: ORR: 47.4% [37.0-57.9] mPFS: 5.8 mos [4.6-6.6 mos] mOS: 18.3 mos