Clinical Trials Search at Vanderbilt-Ingram Cancer Center
Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Added to Radiation or Given by Itself Compared to the Usual Treatment of Chemotherapy with Radiation after Surgery for Recurrent Head and Neck Squamous Cell Carcinoma
Head/Neck
Head/Neck
This phase II trial studies the effect of pembrolizumab in combination with radiation therapy or pembrolizumab alone compared to the usual approach (chemotherapy [cisplatin and carboplatin] plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Carboplatin is also in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab in combination with radiation therapy or pembrolizumab alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma.
Head/Neck
II
Choe, Jennifer
NCT04671667
ECOGHNEA3191
Carboplatin with or without Pembrolizumab in Treating Patients with Advanced Breast Cancer with Locally Recurrent Chest Wall Disease That Cannot Be Removed by Surgery
Breast
Breast
This phase II trial studies the effect of carboplatin with or without pembrolizumab in treating patients with breast cancer that has spread to other places in the body (advanced) with chest wall disease that has come back (locally recurrent) and cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Breast
II
Abramson, Vandana
NCT03095352
VICCBRE1808
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Phase I
Phase I
This is a Phase 1/2, open-label, non-randomized, 4-part Phase 1 trial to determine the safety
profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint
inhibitor (CPI) pembrolizumab (Keytruda).
profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint
inhibitor (CPI) pembrolizumab (Keytruda).
Phase I
I
Davis, Elizabeth
NCT04198766
VICCPHI2135
Testing the Addition of an Anti-cancer drug, BAY 1895344, with Radiation Therapy to the Usual Pembrolizumab Treatment for Recurrent Head and Neck Cancer
Multiple Cancer Types
This phase I trial evaluates the best dose, possible benefits and/or side effects of combination therapy with elimusertib (BAY 1895344), stereotactic body radiation, and pembrolizumab in treating patients with head and neck squamous cell cancer that has come back (recurrent) and cannot be removed by surgery (unresectable). BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving BAY 1895344, stereotactic body radiation therapy in combination with pembrolizumab may shrink or stabilize head and neck squamous cell cancer for longer than treatment with radiation and immunotherapy without BAY 1895344.
Head/Neck,
Phase I
I
Choe, Jennifer
NCT04576091
NCIHNP10405
Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)
Miscellaneous
Miscellaneous
This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo
given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous
cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with
radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in
increasing recurrence free survival (RFS).
given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous
cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with
radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in
increasing recurrence free survival (RFS).
Miscellaneous
III
Choe, Jennifer
NCT03833167
VICCHN18177
A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies
Multiple Cancer Types
ATRC-101-A01 is a Phase 1b, open-label dose escalation and expansion trial of ATRC-101, an
engineered fully human immunoglobulin G, subclass 1 (IgG1) antibody derived from a naturally
occurring human antibody. The safety, tolerability, PK, and biological activity of ATRC-101
will be characterized when administered every two weeks (Q2W) or every 3 weeks (Q3W) as a
monotherapy or in combination with other anticancer agents.
engineered fully human immunoglobulin G, subclass 1 (IgG1) antibody derived from a naturally
occurring human antibody. The safety, tolerability, PK, and biological activity of ATRC-101
will be characterized when administered every two weeks (Q2W) or every 3 weeks (Q3W) as a
monotherapy or in combination with other anticancer agents.
Breast,
Colon,
Lung,
Melanoma,
Non Small Cell,
Ovarian,
Phase I,
Rectal
I
Berlin, Jordan
NCT04244552
VICCPHI2040
Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
Head/Neck
Head/Neck
A Phase 2 Study of Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With
Advanced Head and Neck Squamous Cell Carcinoma.
Advanced Head and Neck Squamous Cell Carcinoma.
Head/Neck
II
Choe, Jennifer
NCT04675294
VICCHN20127
Study of SQZ-eAPC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors
This is a Phase 1/2, first-in-human, open label, multicenter study to assess safety and
tolerability, antitumor activity, and immunogenic and pharmacodynamic effects of SQZ-eAPC-HPV
as monotherapy and in combination with pembrolizumab in patients with recurrent, locally
advanced, or metastatic HPV16+ solid tumors. The study includes patients with head and neck,
cervical, anal, vulvar, or penile cancer.
tolerability, antitumor activity, and immunogenic and pharmacodynamic effects of SQZ-eAPC-HPV
as monotherapy and in combination with pembrolizumab in patients with recurrent, locally
advanced, or metastatic HPV16+ solid tumors. The study includes patients with head and neck,
cervical, anal, vulvar, or penile cancer.
Not Available
I/II
Iams, Wade
NCT05357898
VICCPHI2264
A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers
Multiple Cancer Types
In this study, adults with non-small-cell lung cancer (NSCLC), triple-negative breast cancer
(TNBC) and squamous-cell carcinoma of the head and neck (SCCHN) will be treated with TAK-676
and pembrolizumab following radiotherapy. The main aims of this study are to check if people
are improving after treatment with TAK-676, getting side effects from these combined
treatments, and how much TAK-676 people with these cancers can receive without getting
unacceptable side effects from it.
Participants will receive radiotherapy, then at least 40 hours later will receive
pembrolizumab followed by TAK-676 slowly through a vein (infusion). Participants will receive
an infusion of pembrolizumab at the same dose every 3 weeks. Different small groups of
participants will receive lower to higher doses of TAK-676 on specific days of a 21-day
cycle. This study will be happening at sites in North America.
(TNBC) and squamous-cell carcinoma of the head and neck (SCCHN) will be treated with TAK-676
and pembrolizumab following radiotherapy. The main aims of this study are to check if people
are improving after treatment with TAK-676, getting side effects from these combined
treatments, and how much TAK-676 people with these cancers can receive without getting
unacceptable side effects from it.
Participants will receive radiotherapy, then at least 40 hours later will receive
pembrolizumab followed by TAK-676 slowly through a vein (infusion). Participants will receive
an infusion of pembrolizumab at the same dose every 3 weeks. Different small groups of
participants will receive lower to higher doses of TAK-676 on specific days of a 21-day
cycle. This study will be happening at sites in North America.
Head/Neck,
Lung,
Non Small Cell,
Phase I
I
Iams, Wade
NCT04879849
VICCHNP20120
pB1-11 and TA-HPV Vaccines Combined with Pembrolizumab for the Treatment of Recurrent or Metastatic PD-L1 and HPV Positive Oropharyngeal Cancer
Head/Neck
Head/Neck
This phase II trial tests how well pB1-11 and human papillomavirus tumor antigen (TA-HPV) vaccines in combination with pembrolizumab work in treating patients with oropharyngeal cancer that has come back (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic) and that is PD-L1 and human papillomavirus (HPV) positive. Oropharyngeal cancer is a type of head and neck cancer involving structures in the back of the throat (the oropharynx), such as the non-bony back roof of the mouth (soft palate), sides and back wall of the throat, tonsils, and back third of the tongue. Scientists have found that some strains or types of a virus called HPV can cause oropharyngeal cancer. pBI-11 is a circular deoxyribonucleic acid (DNA) (plasmid) vaccine that promotes antibody, cytotoxic T cell, and protective immune responses. TA-HPV is an investigational recombinant vaccina virus derived from a strain of the vaccina virus which was widely used for smallpox vaccination. Vaccination with this TA-HPV vaccine may stimulate the immune system to mount a cytotoxic T cell response against tumor cells positive for HPV, resulting in decreased tumor growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread by inhibiting the PD-1 receptor. These investigational vaccines could cause or enhance an immune response in the body against HPV, during which time the activity of pembrolizumab against oropharyngeal cancer associated with HPV may be strengthened. These drugs in combination may be more effective in increasing the ability of the immune system to fight oropharyngeal cancer than pembrolizumab alone.
Head/Neck
II
Gibson, Mike
NCT05799144
VICCHN2208
