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Breast

22101 - Ph3 Imlun vs Endo ER+ HER2- BC (EMBER-4) - ON ENROLLMENT HOLD

EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence (J2J-MC-JZLH)

22159 - Ph3 Palb Fulv SOC HR+ HER2- BC CDK4/6 (VIKTORIA-1) - ON ENROLLMENT HOLD

A Phase 3, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy (VIKTORIA-1) (CELC-G-301)

Ph3 HER2/neu BC (FLAMINGO-01)

A Randomized, Multicenter, Placebo-controlled, Phase 3 study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects with Residual Disease or High-Risk PCR after both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01) (GLSI-21-01)

TROPION 5 - A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared with Investigator’s Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients with PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)

TROPION 5 - A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared with Investigator’s Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients with PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)

Colon

21386 - Ph2 RO7198457 CRC ctDNA+ Post Resection - ON ENROLLMENT HOLD

A multi-site, open-label, Phase II, randomized, controlled trial to compare the efficacy of RO7198457 versus watchful waiting in resected, Stage II (high risk) and Stage III colorectal cancer patients who are ctDNA positive following resection (BNT122-01)

Lung (Non Small Cell)

20270 - Ph2 MRTX849 Pembro NSCLC KRAS - ON ENROLLMENT HOLD

A Phase 2 Trial of Adagrasib Monotherapy and in Combination with Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination with Pembrolizumab versus Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation (849-007)

TRITON - A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients

TRITON - A Phase IIIb, Randomized, Multicenter, Open-label Study to assess the Efficacy of Durvalumab plus Tremelimumab versus Pembrolizumab in Combination with Platinum-Based Chemotherapy for First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients with Non-Squamous Histology who have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS

Lymphoma

EPCORE-FL2 - Follicular Lymphoma: Epcoritamab in Combination with R2 Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma

A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma

Melanoma

REGENERON - R3767-ONC-22122 - A PHASE 3 STUDY OF FIXED DOSE COMBINATIONS OF FIANLIMAB AND CEMIPLIMAB VERSUS RELATLIMAB AND NIVOLUMAB IN PARTICIPANTS WITH UNRESECTABLE OR METASTATIC MELANOMA

REGENERON - R3767-ONC-22122 - A PHASE 3 STUDY OF FIXED DOSE COMBINATIONS OF FIANLIMAB AND CEMIPLIMAB VERSUS RELATLIMAB AND NIVOLUMAB IN PARTICIPANTS WITH UNRESECTABLE OR METASTATIC MELANOMA

Observational

21385 - Ph2 Epidemi Colon Cancer - ON ENROLLMENT HOLD

Epidemiological study to determine the prevalence of ctDNA positivity in participants with Stage II (high risk) or Stage III CRC after surgery with curative (R0) intent and subsequent adjuvant chemotherapy with monitoring of ctDNA during clinical follow-up (BNT000-001)

FLEX Registry: Evaluate New Gene Express

MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX Registry)

GEMINI-NSCLC: TP-CA-002 - TEMPUS NSCLC STUDY

TEMPUS GEMINI NSCLC STUDY: A Longitudinal Multi-Omic Biomarker Profiling Study of Patients with Non-Small Cell Lung Cancer (NSCLC)

Ovarian

22201 - Ph3 Mirv Sora +/-Beva FRa+ Epi Ova FT PPC (GLORIOSA) - ON ENROLLMENT HOLD

IMGN853-0421: Randomized, multicenter, open-label, Phase 3 study of mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with folate receptor alpha-high recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancers who have not progressed after second-line platinum-based chemotherapy plus bevacizumab (GLORIOSA)

IMMUNOGEN - IMGN853-0424 - A Randomized Phase 2 Study of Ocular Toxicity Evaluation and Mitigation During Treatment with Mirvetuximab Soravtansine in Patients with Recurrent Ovarian Cancer with High Folate Receptor-Alpha Expression

IMMUNOGEN - IMGN853-0424 - A Randomized Phase 2 Study of Ocular Toxicity Evaluation and Mitigation During Treatment with Mirvetuximab Soravtansine in Patients with Recurrent Ovarian Cancer with High Folate Receptor-Alpha Expression