Pembrolizumab/Vibostolimab Co-Formulation for Oral Squamous Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Fundación Cardiovascular de Colombia ( Site 1423), Floridablanca, Colombia
Oral Squamous Cell Carcinoma+13 More
Pembrolizumab/Vibostolimab Co-Formulation - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of a drug and a light therapy is better than a drug alone in treating cancer.

See full description

Eligible Conditions

  • Oral Squamous Cell Carcinoma
  • Endometrial Neoplasms
  • Hepatocellular Carcinoma
  • Cancer of Stomach
  • Cancer of Esophagus
  • Triple Negative Breast Neoplasms
  • Ovary Cancer
  • Urinary Bladder Cancer
  • Gallbladder Neoplasms
  • Cholangiocarcinoma
  • Uterine Cervical Neoplasms

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Oral Squamous Cell Carcinoma

Study Objectives

This trial is evaluating whether Pembrolizumab/Vibostolimab Co-Formulation will improve 4 primary outcomes and 9 secondary outcomes in patients with Oral Squamous Cell Carcinoma. Measurement will happen over the course of 9 months.

12 months
PFS per RECIST 1.1 as Assessed by Investigator at 12 months
9 months
PFS per RECIST 1.1 as Assessed by Investigator at 9 months
Year 2
Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30] Items 29 and 30)
Change from Baseline in Physical Functioning Score (EORTC QLQ-C30 Items 1-5)
Year 2
DOR per RECIST 1.1 as Assessed by Investigator
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
Number of Participants Who Discontinued Study Intervention Due to an AE
Number of Participants Who Experienced One or More Adverse Events (AEs)
ORR per RECIST 1.1 as Assessed by Investigator
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
PFS per RECIST 1.1 as Assessed by Investigator
Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR
Year 3
Overall Survival (OS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Oral Squamous Cell Carcinoma

Trial Design

9 Treatment Groups

Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab
1 of 9
Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/Oxaliplatin
1 of 9
Pembrolizumab/Vibostolimab Co-Formulation
1 of 9
Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/Cisplatin
1 of 9
Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Hepatocellular Cancer Co...
1 of 9
Pembrolizumab
1 of 9
Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Endometrial Cancer Cohor...
1 of 9
Pembrolizumab/Vibostolimab Co-Formulation + Paclitaxel
1 of 9
Pembrolizumab/Vibostolimab + 5-Fluorouracil + Cisplatin
1 of 9
Experimental Treatment

This trial requires 610 total participants across 9 different treatment groups

This trial involves 9 different treatments. Pembrolizumab/Vibostolimab Co-Formulation is the primary treatment being studied. Participants will be divided into 9 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/BevacizumabParticipants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus carboplatin, paclitaxel, and bevacizumab as background therapy.
Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/OxaliplatinParticipants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus capecitabine and oxaliplatin as background therapy.
Pembrolizumab/Vibostolimab Co-Formulation
Biological
Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion every 3 weeks (Q3W) up to 35 cycles.
Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/CisplatinParticipants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus gemcitabine (until disease progression or unacceptable toxicity) and cisplatin (up to 8 cycles) as background therapy.
Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Hepatocellular Cancer Cohort)Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion Q3W up to 35 cycles, plus lenvatinib 12 mg (body weight [BW] ≥60 kg) or lenvatinib 8 mg (BW <60 kg) qd until meeting discontinuation criteria.
Pembrolizumab
Biological
Participants receive pembrolizumab 200 mg via IV infusion Q3W up to 35 cycles.
Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Endometrial Cancer Cohort)Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion Q3W up to 35 cycles, plus lenvatinib 20 mg once daily (qd) until meeting discontinuation criteria.
Pembrolizumab/Vibostolimab Co-Formulation + PaclitaxelParticipants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus paclitaxel as background therapy until meeting discontinuation criteria.
Pembrolizumab/Vibostolimab + 5-Fluorouracil + CisplatinParticipants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W, plus 5-fluorouracil (5-FU), plus Cisplatin as background therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
FDA approved
Capecitabine
2002
Completed Phase 3
~3010
Oxaliplatin
2003
Completed Phase 4
~4430
Gemcitabine
2017
Completed Phase 3
~2940
Docetaxel
1995
Completed Phase 4
~8840
Carboplatin
2014
Completed Phase 3
~6990
Bevacizumab
2014
Completed Phase 4
~4030
Paclitaxel
FDA approved
Lenvatinib
FDA approved
Cisplatin
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to approximately 3 years for reporting.

Closest Location

Alaska Womens Cancer Care ( Site 1016) - Anchorage, AK

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Oral Squamous Cell Carcinoma or one of the other 13 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
Endometrial cancer
Head and neck squamous cell carcinoma (HNSCC)
Unresectable biliary adenocarcinoma (gallbladder or biliary tree [intrahepatic or extrahepatic] cholangiocarcinoma)
Adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the gastroesophageal junction (GEJ).
Hepatocellular carcinoma (HCC)
Ovarian cancer
You have a history of gastric cancer. show original
You have triple-negative breast cancer. show original
You have urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra. show original

Patient Q&A Section

What is the average age someone gets carcinoma?

"The US population age-adjusted incidence rate (IRR) for all cancers diagnosed during 2011 was 47.8 per 100,000 persons. For carcinomas, IRR was 29.1 per 100,000 persons. The average age at diagnosis of all tumors (excluding lymphoma) was 68.2 yr; for carcinomas, 64.3 yr. Median age at diagnoses of all tumors (excluding lymphoma) was 70 yr; for carcinomas, 66 yr. Median age at diagnosis of breast carcinoma was 63 yr; prostate carcinoma, 62 yr. Median age at diagnosis of colon carcinoma was 60 yr; melanoma, 54 yr." - Anonymous Online Contributor

Unverified Answer

Is pembrolizumab/vibostolimab co-formulation safe for people?

"The safety profile of this regimen was superior to either drug alone, although higher rates of serious infections were observed. Pembrolizumab/vibostolimab co-administration should not be used outside clinical trials due to its risk of infection." - Anonymous Online Contributor

Unverified Answer

How serious can carcinoma be?

"Carcinomas are relatively rare cancers for which advanced detection methods allow for complete removal. In our population, a first carcinoma occurred as early as age 29 in 90% of cases. The five-year survival rate in this group was 77%; however, almost all patients (97%) survived longer than 5 years. We conclude that carcinoma should be considered among the diseases most likely to be detected early in life." - Anonymous Online Contributor

Unverified Answer

Is pembrolizumab/vibostolimab co-formulation typically used in combination with any other treatments?

"PEM/VIB is largely used in combination with immunotherapy or chemotherapy in patients with advanced cancer, including those with HER2+ cancer. Currently, clinical trials are evaluating the efficacy of PEM/VIB in combination with other agents, such as anti-angiogenic agents; anti-proliferative agents; anti-oncolytic agents; targeted therapies; cytotoxic agents; and combinations." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma?

"The prognosis of carcinoma depends on both local and distant factors, including type of tumor, clinicopathologic features, and presence of metastasis. Common treatments for carcinoma include surgery, radiation therapy, chemotherapy, and targeted therapies. Unfortunately, most patients with carcinoma do not survive long enough to receive these treatments. Although there has been great progress in understanding mechanisms of carcinogenesis, further advances are needed before effective chemoprevention strategies can be developed." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating carcinoma?

"The existence of a large number of ongoing studies on anticancer therapies suggests that a large number of new antitumor agents will be discovered during the next few years. However, because of the large number of ongoing studies, the development of new tumor treatments is slow. Whether this reflects an actual lack of new therapeutic agents or whether we have just yet to discover the most effective treatment remains unclear. When the totality of the current evidence is evaluated, it appears that cancer will continue to be a highly important disease in the foreseeable future. We need to be prepared to respond adequately to the enormous challenges posed by cancers.We hope to see these challenges overcome in the future." - Anonymous Online Contributor

Unverified Answer

What does pembrolizumab/vibostolimab co-formulation usually treat?

"Patients with metastatic NSCLC, who received PD1/PDL1 therapy have high rates of durable responses regardless of specific tumor histology or prior chemotherapy. They may benefit from additional antitumor activity provided by an antibody targeting PD-L1. Recent findings of this study pave the way for the development of novel strategies combining PD1/PDL1 blockade and VDA." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma?

"The occurrence of cancer is influenced by many factors (e.g., genetics, environment, nutrition and smoking). In some cases, cancers may arise spontaneously without any known cause; in others, specific genetic alterations trigger the formation of cancer cells. A number of environmental factors, both natural and artificial, can also increase the risk of developing cancer. Tobacco smoking and alcohol consumption are considered to be major risk factors for cancer development. The association between tobacco use and cancer incidence was confirmed in an extensive meta-analysis published in the "Journal of the American Medical Association" in 2006.\n\nTobacco smoke contains more than 60 carcinogens and is one of the main initiators of cancer." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of pembrolizumab/vibostolimab co-formulation?

"All pembrolizumab/vibostolimab formulations showed similar side effects profiles with no significant differences between the 3 different doses evaluated. The most frequent adverse events were fatigue (11%), headache (8%) and nausea (7%). The authors conclude that pembrolizumab/vibostolimub co-formulation is well tolerated at all doses tested." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of carcinoma?

"The main causes of carcinoma are infection, environmental factors, physical factors, and genetic factors. These factors are explained by epidemiological studies.\n\nThe most effective way to prevent cancer is to reduce lifestyle risks such as smoking, drinking alcohol, and obesity." - Anonymous Online Contributor

Unverified Answer

What is carcinoma?

"The word 'carcinoma' comes from the Greek word σάκριον ("sákrion") meaning 'tumour'. It comes from the Ancient Greek καρχίνω ("karchíno") meaning 'to choke', because tumors often obstruct blood flow. It comes from the Greek κάρυγος ("karúgos") meaning 'to swell up', because tumors often grow in big masses. And it comes from the Greek καρέλειον ("kareilein") meaning 'to fill with fat'." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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