Clinical trials: Tumor Microenvironment
Soft Tissue Sarcoma Adult
Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO Device in Soft Tissue Sarcoma
This is a feasibility study in patients with localized or metastatic soft tissue sarcoma undergoing surgery to determine how sarcoma in situ responds to injected microdoses of anti-cancer therapeutics.
- Trial name
- NCT03056599
- Testing
- Multiple drug microinjection, CIVO device
- Where
- 3 sites in United States
- Volunteers
- 23 people
- Sponsor
- Presage Biosciences
Sequence Analysis
Analysis of Tumor Mutations and Tumor Microenvironment Using Archival Paraffin-embedded Tumor Specimens
Genomic alterations have long been recognized as an important factor in tumor formation and drive tumor cell growth. However, the degree of genomic mutation (tumor mutation load, TMB) varies widely between tumors.
- Trial name
- NCT03719222
- Testing
- non intervention
- Where
- Taiwan
- Volunteers
- 600 people
- Sponsor
- ACT Genomics
Head and Neck Squamous Cell Carcinoma
PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592 in HNSCC
This is a multi-center, open-label, Phase 0 substudy designed to evaluate the localized pharmacodynamics (PD) of rilvegostomig, volrustomig, sabestomig, and AZD9592 within the tumor microenvironment (TME) when administered…
- Trial name
- NCT06366451
- Testing
- Rilvegostomig, Volrustomig, Sabestomig
- Where
- 7 sites in United States
- Volunteers
- 17 people
- Sponsor
- Presage Biosciences
Glioblastoma
Glioblastoma Treatment With Irradiation and Olaptesed Pegol (NOX-A12) in MGMT Unmethylated Patients
The purpose of this study is to obtain first, exploratory information on the safety and efficacy of (i) olaptesed pegol in combination with radiation therapy in patients with newly diagnosed glioblastoma of unmethylated MGMT…
- Trial name
- GLORIA (NCT04121455)
- Testing
- Olaptesed pegol, Radiotherapy, Bevacizumab
- Where
- 6 sites in Germany
- Volunteers
- 117 people
- Sponsor
- TME Pharma AG
Pancreas Cancer
L-DOS47 Plus Doxorubicin in Advanced Pancreatic Cancer
This study will evaluate the safety and tolerability of escalating doses of L-DOS47 in combination with doxorubicin, as well as preliminary anti-tumor activity in patients with previously treated advanced pancreatic cancer.
- Trial name
- NCT04203641
- Testing
- L-DOS47, Doxorubicin
- Where
- 3 sites in United States
- Volunteers
- 28 people
- Sponsor
- Helix BioPharma Corporation
Cancer
Particle-based Partial Tumor Irradiation of Unresectable Bulky Tumors
This study uses a novel, recently developed unconventional radiotherapy technique which consists of three high-dose fractions directed to special segments of unresectable bulky tumors.
- Trial name
- PARTICLE-PATHY (NCT04875871)
- Testing
- Particle radiotherapy, Magnetic resonance imaging, Computertomography
- Where
- Austria
- Volunteers
- 13 people
- Sponsor
- EBG MedAustron GmbH
Solid Tumors
Itacitinib Combined With INCB024360 and/or Itacitinib Combined With INCB050465 in Advanced Solid Tumors
This is an open-label, Phase 1b, platform study in subjects with advanced or metastatic solid tumors. The study will be divided into 3 parts (Part 1a, Part 1b, and Part 2).
- Trial name
- NCT02559492
- Testing
- Itacitinib, Epacadostat, INCB050465
- Where
- 11 sites in United States
- Volunteers
- 142 people
- Sponsor
- Incyte Corporation
Advanced Solid Tumor
Less Frequent IV Dosing & Tumor Microenvironment (TME) Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy and in Combination With Pembrolizumab (ARTISTRY-3)
The study will be conducted in 2 cohorts. A single-center design for the tumor microenvironment (TME) cohort (Cohort 1), and a multicenter design for the less frequent intravenous (IV) dosing cohort (Cohort 2).
- Trial name
- ARTISTRY-3 (NCT04592653)
- Testing
- Nemvaleukin alfa, Pembrolizumab
- Where
- 6 sites in United States, Spain
- Volunteers
- 78 people
- Sponsor
- Mural Oncology, Inc
HNSCC
Intratumoral Microdosing of Motolimod in HNSCC
This is a multi-center, single arm, open-label, multi-agent, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of motolimod and motolimod combined with…
- Trial name
- NCT04272333
- Testing
- Motolimod, Nivolumab, Motolimod + Nivolumab
- Where
- 5 sites in United States
- Volunteers
- 1 people
- Sponsor
- Presage Biosciences
Lung Adenocarcinoma
A Study of L-DOS47 in Combination With Vinorelbine/Cisplatin in Lung Adenocarcinoma
This study will determine the highest dose of L-DOS47 that can be given in combination with vinorelbine/cisplatin, evaluate safety and tolerability of L-DOS47 when given in combination with vinorelbine/cisplatin, and assess how…
- Trial name
- NCT03891173
- Testing
- L-DOS47, Cisplatin, Vinorelbine
- Where
- 4 sites in Poland, Ukraine
- Volunteers
- 9 people
- Sponsor
- Helix BioPharma Corporation
Colorectal Cancer (CRC), Endometrial Cancer
Pembrolizumab Combined With Itacitinib (INCB039110) and/or Pembrolizumab Combined With INCB050465 in Advanced Solid Tumors
This is an open-label, multicenter, Phase 1b platform study in subjects with advanced or metastatic solid tumors (Part 1a) and subjects with selected solid tumors (Part 1b and Part 2).
- Conditions
- Colorectal Cancer (CRC), Endometrial Cancer, Melanoma, Head and Neck Cancer
- Trial name
- NCT02646748
- Testing
- Pembrolizumab, itacitinib, INCB050465
- Where
- 17 sites in United States
- Volunteers
- 159 people
- Sponsor
- Incyte Corporation
Solid Tumour
CIVO Intratumoural Microdosing of Anti-Cancer Therapies in Australia
This is a multi-center, open-label Phase 0 Master Protocol in Australia designed to study the localized pharmacodynamics (PD) of anti-cancer therapies within the tumour microenvironment (TME) when administered intratumourally in…
- Trial name
- NCT04891718
- Testing
- MVC-101, Nivolumab, MVC-101 + Nivolumab
- Where
- 3 sites in Australia
- Sponsor
- Presage Biosciences
Solid Tumor
Phase 0 Master Protocol for CIVO Intratumoral Microdosing of Anti-Cancer Therapies
This is a multi-center, open-label Phase 0 Master Protocol designed to study the localized pharmacodynamics (PD) of anti-cancer therapies within the tumor microenvironment (TME) when administered intratumorally in microdose…
- Trial name
- NCT04541108
- Testing
- Rilvegostomig, Volrustomig, Sabestomig
- Where
- 9 sites in United States
- Volunteers
- 15 people
- Sponsor
- Presage Biosciences
Non-Small Cell Lung Cancer
A Phase I/II Open-Label, Non-Randomized Dose Escalation Study of Immunoconjugate L-DOS47
The primary purpose of this research study is to evaluate how safe, how well tolerated and how effective a range of doses of L-DOS47 in patients with non-squamous non-small cell lung cancer when given as a monotherapy.
- Trial name
- NCT02340208
- Testing
- L-DOS47
- Where
- 5 sites in Poland
- Volunteers
- 76 people
- Sponsor
- Helix BioPharma Corporation
Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma Adult
A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0111 in Patients With Solid Tumors
This is a multi-center, single arm, open-label, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of PBA-0111 when administered intratumorally in…
- Conditions
- Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma Adult, Triple Negative Breast Cancer
- Trial name
- NCT06700070
- Testing
- PBA-0111
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Pure Biologics S.A.
Metastatic Colorectal Cancer, Metastatic Pancreatic Cancer
Olaptesed (NOX-A12) Alone and in Combination With Pembrolizumab in Colorectal and Pancreatic Cancer
The purpose of this study is to show that the type, number and/or distribution of tumor metastases infiltrating immune cells such as cytotoxic T cells and/or the cytokine signature in the tumor metastases can be modulated by…
- Trial name
- Keynote-559 (NCT03168139)
- Testing
- Olaptesed pegol - Monotherapy, Olaptesed pegol + Pembrolizumab - Combination Therapy
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- TME Pharma AG
Solid Tumor, Adult
A Study of MTL-CEBPA in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumours (TIMEPOINT)
This is an open label Phase 1a/1b study in patients who have advanced solid cancer tumours. Patients will receive MTL-CEBPA (an experimental drug) in combination with pembrolizumab (a drug which has been given approval for use…
- Trial name
- TIMEPOINT (NCT04105335)
- Testing
- MTL-CEBPA, Pembrolizumab
- Where
- 3 sites in United Kingdom
- Volunteers
- 50 people
- Sponsor
- Mina Alpha Limited
Solid Tumors, Advanced Malignancies
Azacitidine Combined With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors (ECHO-206)
This is an open-label, Phase 1/2 study in subjects with advanced or metastatic solid tumors. The study has three separate treatment groups where separate epigenetic agents are evaluated with an immunotherapy combination.
- Conditions
- Solid Tumors, Advanced Malignancies, Metastatic Cancer
- Trial name
- NCT02959437
- Testing
- Azacitidine, Pembrolizumab, Epacadostat
- Where
- 12 sites in United States, Spain and 1 more
- Volunteers
- 70 people
- Sponsor
- Incyte Corporation
Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma
PBI-MST-01 (NCT04541108) Substudy MSD-03: Intratumoral Microdosing of Pembrolizumab Alone and With MK-0482 or MK-4830 in HNSCC or STS
This is a multi-center, open-label, Phase 0 substudy designed to evaluate the ability of pembrolizumab, alone and in combination with MK-0482 or MK-4830, to elicit pharmacodynamic changes suggestive of antitumor immune activation…
- Trial name
- NCT06413095
- Testing
- Pembrolizumab, MK-0482 + Pembrolizumab, MK-4830 + Pembrolizumab
- Where
- 11 sites in United States
- Volunteers
- 13 people
- Sponsor
- Presage Biosciences
Non-Small Cell Lung Cancer
A Dose Escalation Study of L-DOS47 in Recurrent or Metastatic Non-Squamous NSCLC
The primary purpose of this research study is to evaluate how safe, how well tolerated and how effective a range of doses of L-DOS47 in combination with standard doublet therapy of pemetrexed/carboplatin in patients with Stage IV…
- Trial name
- NCT02309892
- Testing
- L-DOS47
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- Helix BioPharma Corporation