Clinical trials: Neoadjuvant Treatment
Gastric Cancer
Docetaxel + Oxaliplatin + S-1 in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma
The primary objective of this trial is: To determine whether it is feasible in locally advanced gastric or gastroesophageal cancer to administer 3 cycles of Docetaxel, Oxaliplatin and S-1 as a chemotherapy scheme and also to…
- Trial name
- NCT00816543
- Testing
- DOCETAXEL, S-1, OXALIPLATIN
- Where
- South Korea
- Volunteers
- 41 people
- Sponsor
- Sanofi
Renal Cell Cancer
A Study Evaluating the Effect of Pembrolizumab (MK-3475) in Participants With Renal Cell Cancer (MK-3475-031)
This study will examine the effect of treatment with the neoadjuvant antibody pembrolizumab (MK-3475) on tumors of participants with renal cell cancer (RCC).
- Trial name
- NCT02212730
- Testing
- Pembrolizumab Pre-Resection, Surgical Resection, Pembrolizumab Post-Resection
- Volunteers
- 10 people
- Sponsor
- Merck Sharp & Dohme LLC
Hemophilia A, Congenital
Alphanate in Immune Tolerance Induction Therapy
This is a multicenter, multinational, prospective, single-arm, nonrandomized, open-label study, planned in of approximately 25 male participants with congenital hemophilia A who will receive their first (primary) immune tolerance…
- Trial name
- NCT03095287
- Testing
- Alphanate
- Where
- 20 sites in United States, Canada and 4 more
- Volunteers
- 2 people
- Sponsor
- Grifols Therapeutics LLC
Breast Cancer, Cancer
A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer
A randomized multi-arm study evaluating the safety and efficacy of palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer
- Trial name
- CheckMate 7A8 (NCT04075604)
- Testing
- Nivolumab, Anastrozole, Palbociclib
- Where
- 36 sites in United States, Australia and 6 more
- Volunteers
- 23 people
- Sponsor
- Bristol-Myers Squibb
Breast Neoplasms
GETNA2 Neoadj. TAX+Femara vs Femara in g I/II Breast Cancer
Primarily to evaluate the rates of clinical and radiological response in the 2 groups. Secondarily rate of histological response.
- Trial name
- NCT00617968
- Testing
- DOCETAXEL
- Where
- France
- Volunteers
- 5 people
- Sponsor
- Sanofi
Breast Cancer
A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery
This trial is a Phase 2 neoadjuvant study evaluating ARV-471 or anastrozole in post-menopausal women with estrogen receptor positive/ human epidermal growth factor receptor 2 (ER+/HER2)- localized breast cancer.
- Trial name
- NCT05549505
- Testing
- ARV-471, Anastrozole, Surgical resection of breast tumor
- Where
- 49 sites in United States, Georgia and 2 more
- Volunteers
- 152 people
- Sponsor
- Arvinas Inc.
Non-Small Cell Lung Cancer
Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
The aim of the study to evaluate the safety and efficacy of Sacituzumab Tirumotecan in combination with osimertinib for neoadjuvant treatment in patients with resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small…
- Trial name
- NCT07329322
- Testing
- Sacituzumab Tirumotecan, Osimertinib
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Colorectal Carcinoma
Neoadjuvant Recombinant Vaccinia Virus for Metastatic Colorectal Cancer With Liver Resection
This is a neoadjuvant Phase 2a, open-label trial in patients with metastatic colorectal carcinoma who are undergoing a complete resection of the metastatic colorectal tumors in their liver.
- Trial name
- NCT01329809
- Testing
- Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
- Where
- Canada
- Volunteers
- 2 people
- Sponsor
- Jennerex Biotherapeutics
Acute Myeloid Leukemia
A Study Assessing tOTX015 in Combination With Azacitidine (AZA) or AZA Single Agent in Patients With Newly-diagnosed Acute Myeloid Leukemia (AML) Not Candidate for Standard Intensive Induction Therapy (SIIT)
This study is designed in its first part (phase Ib) to determine the recommended dose of the OTX015 + Vidaza (azacitidine) combination in newly diagnosed acute myeloid leukemia patients not candidate for standard intensive…
- Trial name
- NCT02303782
- Testing
- OTX015, Vidaza (azacitidine)
- Sponsor
- Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Crohn's Disease
Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)
The purpose of this study is to evaluate the efficacy and safety of Ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.
- Trial name
- CARMEN CD 306 (NCT03566823)
- Testing
- Ontamalimab
- Where
- 145 sites in United States, Argentina and 18 more
- Volunteers
- 34 people
- Sponsor
- Shire
Crohn's Disease, Inflammatory Bowel Disease
A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)
This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.
- Conditions
- Crohn's Disease, Inflammatory Bowel Disease, IBD, Colitis
- Trial name
- NCT01369342
- Testing
- Group 2 ustekinumab 130 mg, Group 3: ustekinumab approximately 6 mg/kg
- Where
- 220 sites in United States, Australia and 20 more
- Volunteers
- 640 people
- Sponsor
- Janssen Research & Development, LLC
Head and Neck Cancer, Head and Neck (HNSCC)
APG-157 in Locally Advanced Head and Neck Squamous Cell Carcinoma
This Phase 3, multicenter, randomized, open-label study evaluates APG-157 in adults with newly diagnosed locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
- Conditions
- Head and Neck Cancer, Head and Neck (HNSCC), Oropharyngeal, Oral Cavity
- Trial name
- NCT07667296
- Testing
- APG-157, Surgery, Radiation/Chemotherapy
- Volunteers
- 826 people
- Sponsor
- Aveta Biomics, Inc.
Rectal Cancer
An Extended Feasibility Phase I/II Study of Methylenetetrahydrofolate (Arfolitixorin) and Pemetrexed Single Agent, Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer
The purpose of this study is to determine whether an optimal dose of [6R] 5,10-methylenetetrahydrofolate (arfolitixorin) in combination with pemetrexed are effective in pre-operative treatment of patients with resectable rectal…
- Trial name
- NCT01397305
- Testing
- [6R] 5,10-methylenetetrahydrofolate (arfolitixorin), Pemetrexed
- Where
- Sweden
- Volunteers
- 24 people
- Sponsor
- Isofol Medical AB
Hormone-receptor-positive Breast Cancer, HER2-low Breast Cancer
Study of Predictors of Clinical Outcomes in Patients With HR+ and HER2-low/Negative Breast Cancer
There is a lack of data on clinical and patient factors that are associated with poor survival in patients with HR+ and HER2-low/negative breast cancer treated with neoadjuvant chemotherapy or endocrine therapy.
- Conditions
- Hormone-receptor-positive Breast Cancer, HER2-low Breast Cancer, HER2-negative Breast Cancer
- Trial name
- NCT06040593
- Testing
- No drug
- Where
- United States
- Volunteers
- 927 people
- Sponsor
- Daiichi Sankyo
Breast Cancer
NBRST: Prospective Neo-adjuvant REGISTRY Trial
The scope of this registry study is to measure chemosensitivity as defined by pCR (primary endpoint), or endocrine sensitivity as defined by partial response (decrease in longest tumor diameter or residual cancer burden category…
- Trial name
- NBRST (NCT01479101)
- Testing
- MammaPrint 70-gene expression profile, BluePrint 80 gene expression profile
- Where
- 76 sites in United States
- Volunteers
- 1,142 people
- Sponsor
- Agendia
Early Breast Cancer
A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)
The current study will compare PK, efficacy, safety, and immunogenicity of PF-05280014 (Trastuzumab-Pfizer) in combination with Taxotere® and Carboplatin (Paraplatin) versus Herceptin® (Trastuzumab-EU) approved in the EU in…
- Trial name
- NCT02187744
- Testing
- PF-05280014, Taxotere®, Paraplatin®
- Where
- 52 sites in United States, Belarus and 8 more
- Volunteers
- 226 people
- Sponsor
- Pfizer
Stomach Neoplasms
Docetaxel in Locally Advanced Gastric Adenocarcinoma
Study objectives: To determine Ro resection rate of Docetaxel, cisplatin and fluorouracil combination for the treatment of neoadjuvant gastric carcinoma.
- Trial name
- NEOTAX (NCT00343239)
- Testing
- Docetaxel, Cisplatin, Fluorouracil
- Where
- Turkey (Türkiye)
- Volunteers
- 59 people
- Sponsor
- Sanofi
Melanoma Stage III
The Efficacy and Safety of PRTX007-003 Combined With Pembrolizumab in Resectable Stage III Melanoma
This Phase 2, multi-center, single-arm study evaluates the safety, tolerability, and activity of neoadjuvant PRTX007 in combination with pembrolizumab in participants with resectable Stage III melanoma.
- Trial name
- INFLECTION-003 (NCT07565285)
- Testing
- PRTX007, Pembrolizumab
- Where
- 7 sites in Australia
- Volunteers
- 48 people
- Sponsor
- Primmune Therapeutics, Inc.
Gastric Cancer
Docetaxel+Oxaliplatin+S-1 (DOS) Regimen as Neoadjuvant Chemotherapy in Advanced Gastric Cancer
Primary Objective: To compare the 3-year progression free survival (PFS) in the two treatment arms. Secondary Objectives: Overall survival (OS). Postoperative pathological stage and R0 (complete) resection rate.
- Trial name
- PRODIGY (NCT01515748)
- Testing
- Docetaxel (XRP6976), Oxaliplatin (SR96669), S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + 5-chloro-2, 4-dihydroxypyridine (CDHP) (Gimeracil) + Oxo (Oteracil)
- Where
- South Korea
- Volunteers
- 530 people
- Sponsor
- Sanofi
Ulcerative Colitis
Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis
The primary objective of the study is to determine the efficacy of Asacol™ 4.8 g/day (800 mg tablets) to induce clinical and endoscopic remission after 6 weeks of treatment compared to placebo in subjects with active ulcerative…
- Trial name
- NCT01059344
- Testing
- Mesalamin
- Where
- 31 sites in Belarus, India and 2 more
- Volunteers
- 281 people
- Sponsor
- Tillotts Pharma AG