CJRB-101 + Pembrolizumab for Advanced Cancer

Recruiting at 6 trial locations

Overseen By Hyun Kim

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: CJ Bioscience, Inc.

Must not be taking: Antibacterials, Antifungals, Antivirals, others

Disqualifiers: Autoimmune, Brain metastasis, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination for individuals with advanced or metastatic cancers resistant to existing immune therapies. The study evaluates the safety and effectiveness of combining CJRB-101 (an experimental treatment) with pembrolizumab (an immune therapy drug) by assessing treatment efficacy, side effects, and bodily impact. Individuals with lung cancer, head and neck cancer, or melanoma unresponsive to other treatments may qualify. Participants should have one measurable tumor that remains untreated by surgery or radiation. As a Phase 1, Phase 2 trial, this research aims to understand the treatment's function in people and measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, certain conditions like active infections requiring treatment or recent use of live vaccines may affect eligibility. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that pembrolizumab, also known as Keytruda, is generally safe for treating various cancers. It has been used in many studies and is considered well-tolerated, though some side effects, like fatigue and cough, have been reported.

Less information exists on CJRB-101 because it is newer and still under study. In this trial's early stages, researchers focus on ensuring CJRB-101's safety for humans before assessing its effectiveness. Participants receive close monitoring for any side effects.

Combining CJRB-101 with pembrolizumab involves studying how these drugs interact and whether they cause any new side effects. This trial aims to provide researchers with more insights into these interactions. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for advanced cancer?

Researchers are excited about CJRB-101 combined with pembrolizumab because it offers a potentially powerful new approach for treating advanced cancer. Unlike traditional treatments that mainly target cancer cells, CJRB-101 works by modulating the immune system, enhancing the body's natural ability to fight tumors. This combination with pembrolizumab, an established immunotherapy, might boost its effectiveness, potentially leading to better outcomes for patients with tough-to-treat cancers. By potentially improving the immune response, this combo could offer a new hope for patients who have limited treatment options.

What evidence suggests that this trial's treatments could be effective for advanced cancer?

Research has shown that pembrolizumab effectively treats various types of cancer. It has been particularly successful in extending the lives of patients with advanced non-small cell lung cancer and metastatic melanoma compared to standard treatments. This trial tests CJRB-101 in combination with pembrolizumab. Although information on CJRB-101 is limited, the combination aims to assist patients who do not respond well to pembrolizumab alone. The goal is to address the needs of people with advanced cancers. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain advanced cancers (NSCLC, HNSCC, or melanoma) that haven't been treated yet or didn't respond to previous treatments. Participants need a measurable cancer lesion and specific PD-L1 expression levels depending on their cancer type. They shouldn't have had systemic treatment for metastatic disease but can join if it's been 6+ months since adjuvant therapy.

Inclusion Criteria

Willing and able to provide informed consent

I am fully active or can carry out light work.

My organs are functioning well.

Exclusion Criteria

In the judgment of the investigator, subjects unlikely to comply with study procedures, restrictions and requirements

I have had major surgery on my digestive system.

My lung cancer has specific genetic changes in EGFR or ALK.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Participants receive either low or high dose levels of CJRB-101 in combination with pembrolizumab to assess safety and dose limiting toxicities

Maximum 2 years

Phase 2 Treatment

Participants receive the selected dose of CJRB-101 from Phase 1 in combination with pembrolizumab to assess efficacy

Maximum 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CJRB-101
• Pembrolizumab

Trial Overview The study tests CJRB-101 combined with pembrolizumab injections in patients with selected advanced cancers. It aims to improve response rates where immune checkpoint inhibitors alone aren’t enough by evaluating safety, tolerability, dose limits, and effects on microbiome biomarkers.

How Is the Trial Designed?

Group I: CJRB-101 with pembrolizumab Experimental Treatment 2 Interventions

Phase 1 includes patients with selected types of advanced or metastatic cancers. Patients will be given with either low or high dose levels of CJRB-101 in combination with pembrolizumab. Phase 2 includes patients with selected types of advanced or metastatic cancers. Patients will be given with the CJRB-101 dose selected from Phase 1 in combination with pembrolizumab.

CJRB-101 is already approved in United States for the following indications:

Approved in United States as CJRB-101 for:

• Advanced or metastatic NSCLC
• Advanced or metastatic HNSCC
• Advanced or metastatic melanoma

Who Is Running the Clinical Trial?

CJ Bioscience, Inc.

Lead Sponsor

Trials

1

Recruited

160+

Published Research Related to This Trial

Pembrolizumab (Keytruda) is the first anti-PD-1 therapy approved in the US for treating advanced malignant melanoma, specifically for patients who have progressed after prior treatments.

It is designed to target the PD-1 protein, enhancing the immune system's ability to fight cancer, and is currently under review for approval in the EU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab: first global approval. Poole, RM.[2021]

In a study of 24 patients with advanced non-small cell lung cancer (NSCLC) treated with pembrolizumab, the objective response rate was 45.8%, indicating that nearly half of the patients experienced a reduction in tumor size after treatment.

Pembrolizumab showed promising results even in PD-L1-negative patients, with a major pathological response of 75% and a pathological complete response of 50% in those who underwent surgery, suggesting its potential effectiveness across different patient profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of pembrolizumab for the treatment of advanced non-small cell lung cancer: a retrospective, single-centre, single-arm study. Guo, T., Ding, Y., Chen, L., et al.[2022]

In a study of 145 patients with PD-L1 strongly positive non-small-cell lung cancer (NSCLC), those with higher PD-L1 expression (≥ 75%) experienced better treatment outcomes with pembrolizumab, showing a higher objective response rate (51% vs. 33%) and longer progression-free survival (13.9 months vs. 5.2 months).

Patients with liver metastasis had significantly poorer responses to pembrolizumab, with an objective response rate of only 20% compared to 47% in those without liver metastasis, indicating that both PD-L1 expression and liver metastasis are important predictors of treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential Efficacy of Pembrolizumab According to Metastatic Sites in Patients With PD-L1 Strongly Positive (TPS ≥ 50%) NSCLC. Takeyasu, Y., Yoshida, T., Shibaki, R., et al.[2021]

In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.

The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]

In a real-life study of 121 patients with advanced non-squamous non-small cell lung cancer, the combination of pembrolizumab and chemotherapy resulted in a median progression-free survival of 9 months and overall survival of 20.6 months, demonstrating its efficacy as a first-line treatment.

The treatment was generally well-tolerated, with manageable side effects; however, 17.5% of patients experienced grade 3-4 adverse events, and there were two treatment-related deaths, indicating the need for careful monitoring during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab plus pemetrexed-carboplatin combination in first-line treatment of advanced non-squamous non-small cell lung cancer: a multicenter real-life study (CAP29). Renaud, E., Ricordel, C., Corre, R., et al.[2023]

Pembrolizumab, a PD-1 inhibitor used in cancer treatment, can lead to rare but serious immune-related adverse events, including type 1 diabetes mellitus, occurring in about 0.2% of cases.

A review of 42 cases revealed that patients may develop diabetic ketoacidosis during treatment, highlighting the need for blood glucose monitoring and awareness of this potential side effect among clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. Clotman, K., Janssens, K., Specenier, P., et al.[2022]

Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.

Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. Karim, S., Leighl, N.[2017]

Pembrolizumab (Keytruda) is an approved treatment for metastatic or locally advanced esophageal and gastroesophageal junction cancer, indicating its efficacy in targeting these specific cancer types.

It is used in combination with platinum- and fluoropyrimidine-based chemotherapy, suggesting a synergistic approach to enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab Approved for Esophageal or Gastroesophageal Cancer. Aschenbrenner, DS.[2023]

Pembrolizumab (KEYTRUDA) was approved by the FDA for treating advanced melanoma, showing an overall response rate of 24% in a trial of 89 patients, with 86% of responses lasting at least 6 months.

While there are potential immune-mediated side effects, the benefits of prolonged tumor response durations were deemed to outweigh these risks, marking an improvement over existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. Chuk, MK., Chang, JT., Theoret, MR., et al.[2021]

Pembrolizumab, an immune checkpoint inhibitor, can cause pneumonitis in 1%-5% of patients, and this case report highlights an atypical presentation of this side effect in a patient with metastatic squamous cell carcinoma.

The patient was successfully treated with steroid therapy after ruling out other potential causes, leading to complete resolution of the pneumonitis, emphasizing the importance of recognizing and managing atypical cases of checkpoint inhibitor-pneumonitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. Jeon, WJ., Nguyen, J., Castillo, DR., et al.[2023]

In a study of 655 patients with advanced melanoma, pembrolizumab showed a 5-year overall survival rate of 34%, with even better outcomes (41%) for treatment-naive patients, indicating its long-term efficacy.

The treatment was generally well-tolerated, with 86% of patients experiencing treatment-related adverse events, but only 7.8% discontinued due to these effects, suggesting a manageable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001. Hamid, O., Robert, C., Daud, A., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40157574/

the phase III 3475A-D77 trial Results support pembrolizumab s.c. as a treatment option in all indications where pembrolizumab i.v. can be used. Keywords: immunotherapy; non-small-cell lung ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05877430

Safety, Tolerability, and Preliminary Efficacy of CJRB-101 ... Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer. ClinicalTrials.

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Study Description Study CJB-101-01 will be conducted at multiple centers in the USA and Republic of Korea as an open-label safety and preliminary efficacy study ...

4. withpower.com withpower.com/trial/phase-2-neoplasm-metastasis-8-2023-41eb9

CJRB-101 + Pembrolizumab for Advanced Cancer Pembrolizumab, a part of the treatment, has been shown to be effective in treating various cancers, including advanced non-small cell lung cancer and metastatic ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01704287

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A Phase II Clinical Trial of Pembrolizumab (MK-3475) in ... This is a study using pembrolizumab (MK-3475, KEYTRUDA®) for first-line treatment of participants with advanced/unresectable (inoperable) or metastatic ...