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PD-1 Inhibitor

Regorafenib + Nivolumab for Cancer

Phase 2
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cohort 2: subjects with HNSCC who have progressed on or after prior systemic therapy, at least one of which included a PD-1/PD-L1 inhibitor alone or in combination with chemotherapy.
Cohort 4: subjects with PDAC (Pancreatic ductal adenocarcinoma) who have progressed on or after gemcitabine or fluoropyrimidine based regimens.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dosing up to the end of the study (lplv), summing up to approximately 4 years
Awards & highlights

Study Summary

This trial is testing a combination of two drugs, regorafenib and nivolumab, to see if they are safe and effective in treating people with different types of solid tumors.

Who is the study for?
Adults with certain advanced solid tumors that have worsened after standard treatments can join this trial. It's for those who can take pills, consent to provide tissue samples, and are in good enough health as judged by specific medical tests. People with severe heart conditions, active infections above a mild level, or immune diseases; pregnant or breastfeeding individuals; and those allergic to the drugs cannot participate.Check my eligibility
What is being tested?
The trial is testing if combining Regorafenib (a cancer tablet) with Nivolumab (an IV cancer drug) helps patients better than current methods. About 200 participants will receive both drugs in cycles: daily Regorafenib for three weeks followed by a week off, and Nivolumab once every four weeks for up to two years.See study design
What are the potential side effects?
Possible side effects include fatigue, high blood pressure, hand-foot skin reactions from Regorafenib; plus immune-related issues like inflammation of organs or skin problems from Nivolumab. Side effects vary per person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have head and neck cancer that got worse after treatment, including a PD-1/PD-L1 inhibitor.
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My pancreatic cancer worsened after treatment with gemcitabine or fluoropyrimidine.
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I have head and neck cancer and haven't had PD-1/PD-L1 inhibitor therapy.
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I am 18 years old or older.
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I have biliary tract cancer and my condition worsened after treatment with specific chemotherapy drugs.
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My throat cancer has been tested for HPV.
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I have head and neck cancer and haven't had PD-1/PD-L1 inhibitor therapy.
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My recent blood and organ function tests are within normal ranges.
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I have a high-grade brain tumor and it has worsened after initial treatments.
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I have biliary tract cancer and my condition worsened after treatment with specific chemotherapy drugs.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My liver enzymes are within the acceptable range for my condition.
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I can swallow and absorb pills.
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I have head and neck cancer that got worse after treatment, including a PD-1/PD-L1 inhibitor.
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I am 18 years old or older.
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I agree to provide a recent biopsy of my tumor for the study.
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My cancer has returned or spread and doesn't respond to standard treatments anymore.
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I have a high-grade brain tumor and it has worsened after initial treatments.
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My pancreatic cancer worsened after treatment with gemcitabine or fluoropyrimidine.
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I can swallow and absorb pills.
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My esophageal cancer worsened after treatment with platinum or fluoropyrimidine.
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I can sign and follow the study's consent form and rules.
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My throat cancer has been tested for HPV.
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I am fully active or can carry out light work.
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My recent blood and organ function tests are within normal ranges.
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My cancer has returned or spread and doesn't respond to standard treatments anymore.
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My esophageal cancer worsened after treatment with platinum or fluoropyrimidine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dosing up to the end of the study (lplv), summing up to approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dosing up to the end of the study (lplv), summing up to approximately 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
1 year OS
6 months PFS
Disease control rate (DCR)
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Regorafenib+NivolumabExperimental Treatment2 Interventions
Parallel-cohort in adult participants with selected recurrent or metastatic tumors (HNSCC, ESCC, PDAC, BTC, and GBM/AA) who have been previously treated with one or more systemic therapy for the selected tumor indication.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab (Opdivo)
2019
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,229 Previous Clinical Trials
25,325,262 Total Patients Enrolled
Bristol Myers Squibb Co. and Ono Pharmaceutical Co., LtdUNKNOWN

Media Library

Nivolumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04704154 — Phase 2
Solid Tumors Research Study Groups: Regorafenib+Nivolumab
Solid Tumors Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04704154 — Phase 2
Nivolumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04704154 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different settings is this experiment being conducted?

"There are 11 total sites for this trial, including Henry Ford Health System in Detroit, Michigan, Rocky Mountain Cancer Centers in Aurora, Colorado, and H. Lee Moffitt Cancer Center & Research Institute in Tampa, Florida."

Answered by AI

To your knowledge, does this research have any precedent?

"796 medical studies are currently underway to test the efficacy of nivolumab (Opdivo). Medarex first conducted a Phase 1 trial in 2010 with 127 patients. Since then, 327 similar trials have been completed across 2441 cities and 51 countries."

Answered by AI

Has Nivolumab (Opdivo) been used in other research studies?

"Nivolumab (Opdivo), first studied in 2010, has had 327 completed clinical trials. As of now, there are 796 active studies being conducted with many taking place in Detroit, Michigan."

Answered by AI

How many people suffering from this ailment can join this clinical trial?

"Recruitment for this trial has closed. The study was initially posted on February 3rd, 2021 and edited for the last time on October 20th, 2022. If you are looking for similar studies, 2678 trials involving tumors and 796 investigations using Nivolumab (Opdivo) are still recruiting patients."

Answered by AI

Are there long-term risks associated with Nivolumab (Opdivo)?

"Nivolumab (Opdivo) is a phase 2 medication, meaning that while there is some evidence for its safety, none exists yet to support efficacy."

Answered by AI

What are some off-label indications for Nivolumab?

"Nivolumab (Opdivo) is commonly used to treat malignant neoplasms, but it can also be effective in treating other conditions like unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

Are people currently being signed up for this experiment?

"This clinical trial is not currently enrolling patients. This study was first posted on February 3rd, 2021 and was last updated on October 20th, 2022. However, there are 2678 other trials for patients with tumors recruiting and 796 studies involving Nivolumab that are still looking for participants."

Answered by AI
~43 spots leftby Mar 2025