~16 spots leftby Apr 2026

TAK-500 + Pembrolizumab for Advanced Solid Cancers

Recruiting in Palo Alto (17 mi)
+13 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Takeda
No Placebo Group
Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called TAK-500, alone or with pembrolizumab, in adults with advanced or spreading solid tumors. The goal is to see if TAK-500 is safe and effective in shrinking these tumors.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot have had certain treatments like other STING agonists/antagonists, Toll-like receptor agonists, or CCR2 agonists/antagonists within the past 6 months. Also, you must not have received any investigational products or anticancer therapy within 14 days or 5 half-lives before starting the study drug. It's best to discuss your current medications with the study doctor.

What data supports the idea that TAK-500 + Pembrolizumab for Advanced Solid Cancers is an effective drug?

The available research shows that pembrolizumab, a part of the TAK-500 + Pembrolizumab combination, has been effective in treating certain types of cancer. For example, in patients with advanced non-small cell lung cancer, pembrolizumab improved survival rates compared to traditional chemotherapy. In one study, patients who received pembrolizumab lived longer and had a longer period before their cancer got worse compared to those who received chemotherapy. Additionally, pembrolizumab has shown benefits in treating advanced melanoma, where it improved survival and response rates compared to other treatments. These results suggest that pembrolizumab, when combined with TAK-500, could be an effective option for treating advanced solid cancers.12345

What safety data is available for TAK-500 and Pembrolizumab in treating advanced solid cancers?

Pembrolizumab, also known as KEYTRUDA or MK-3475, has been evaluated in various clinical trials for different cancers. Safety data from these trials indicate that common adverse reactions include fatigue, cough, nausea, pruritus, rash, decreased appetite, constipation, arthralgia, and diarrhea. Immune-mediated adverse reactions such as pneumonitis, colitis, hepatitis, hypophysitis, and thyroid disorders have also been reported. Pembrolizumab has shown clinical activity in solid tumors and is approved for certain cancers, but it can cause serious side effects like pneumonitis in 1%-5% of patients. There is no specific safety data provided for TAK-500 in the provided research.25678

Is the drug Pembrolizumab (also known as Keytruda or MK-3475) a promising treatment for advanced solid cancers?

Yes, Pembrolizumab is a promising drug for advanced solid cancers. It has been approved for treating various cancers, including endometrial carcinoma, non-small-cell lung cancer, melanoma, and esophageal cancer. It works by helping the immune system fight cancer cells, and studies have shown it can improve survival rates and response to treatment.245910

Research Team

SD

Study Director

Principal Investigator

Takeda

Eligibility Criteria

Adults with certain advanced or metastatic solid tumors, including various cancers like lung, liver, breast, and stomach cancer. Participants must be in good physical condition (ECOG 0-1), have measurable disease per RECIST criteria, adequate organ function, and no severe side effects from previous treatments. They should not have heart issues or active hepatitis among other exclusions.

Inclusion Criteria

My liver function is relatively good (Child-Pugh A or B7).
My cancer has worsened or I can't tolerate standard treatments.
My blood, kidney, and liver tests are within normal ranges.
See 10 more

Exclusion Criteria

I have ongoing hepatitis B or C.
I haven't taken any experimental or cancer treatments in the last 14 days or 5 half-lives, whichever is shorter.
I have received a stem cell or organ transplant.
See 18 more

Treatment Details

Interventions

  • Pembrolizumab (Monoclonal Antibodies)
  • TAK-500 (Other)
Trial OverviewThe trial is testing TAK-500 alone or combined with pembrolizumab to evaluate safety and anti-tumor effects in adults with specific advanced cancers. Treatment can last up to a year but will stop if the disease progresses or at the doctor's discretion.
Participant Groups
9Treatment groups
Experimental Treatment
Group I: Dose Expansion: 3L RCC: TAK-500 + Pembrolizumab (RDE 1)Experimental Treatment2 Interventions
Participants with 3L renal clear cell carcinoma (RCC) will receive TAK-500, infusion, intravenously, in a 42-day treatment cycle (Q2W or Q3W) with pembrolizumab 200 mg infusion, intravenously, in a 42-day treatment cycle (Q3W) for up to 1 year. The recommended dose (RDE 1) and schedule of TAK-500 for expansion will be based on the results of the TAK-500 in combination with pembrolizumab Dose Escalation arm.
Group II: Dose Expansion: 3L NSCLC: TAK-500 (RDE 2) SAExperimental Treatment1 Intervention
Participants with 3L NSCLC will receive TAK-500, infusion, intravenously, in a 42-day treatment cycle (Q2W or Q3W) for up to 1 year. The recommended dose (RDE 2) and schedule of TAK-500 for expansion will be based on the results of the TAK-500 as single agent in Dose Escalation arm.
Group III: Dose Expansion: 3L NSCLC: TAK-500 (RDE 1) SAExperimental Treatment1 Intervention
Participants with third-line (3L) NSCLC will receive TAK-500, infusion, intravenously, in a 42-day treatment cycle (Q2W or Q3W) for up to 1 year. The recommended dose (RDE 1) and schedule of TAK-500 for expansion will be based on the results of the TAK-500 as single agent in Dose Escalation arm.
Group IV: Dose Expansion: 2L Pancreatic Adenocarcinoma: TAK-500 + Pembrolizumab (RDE 1)Experimental Treatment2 Interventions
Participants with 2L Pancreatic Adenocarcinoma will receive TAK-500, infusion, intravenously, in a 42-day treatment cycle (Q2W or Q3W) with pembrolizumab 200 mg infusion, intravenously, in a 42-day treatment cycle (Q3W) for up to 1 year. The recommended dose (RDE 1) and schedule of TAK-500 for expansion will be based on the results of the TAK-500 in combination with pembrolizumab Dose Escalation arm.
Group V: Dose Expansion: 2L Pancreatic Adeno: TAK-500 (RDE 1) SAExperimental Treatment1 Intervention
Participants with 2L Pancreatic Adenocarcinoma will receive TAK-500, infusion, intravenously, in a 42-day treatment cycle (Q2W or Q3W) for up to 1 year. The recommended dose (RDE 1) and schedule of TAK-500 for expansion will be based on the results of the TAK-500 as single agent in Dose Escalation arm.
Group VI: Dose Expansion: 2L NSCLC: TAK-500 + Pembrolizumab (RDE 2)Experimental Treatment2 Interventions
Participants with 2L NSCLC will receive TAK-500, infusion, intravenously, in a 42-day treatment cycle (Q2W or Q3W) with pembrolizumab 200 mg infusion, intravenously, in a 42-day treatment cycle (Q3W) for up to 1 year. The recommended dose (RDE 2) and schedule of TAK-500 for expansion will be based on the results of the TAK-500 in combination with pembrolizumab Dose Escalation arm.
Group VII: Dose Expansion: 2L NSCLC: TAK-500 + Pembrolizumab (RDE 1)Experimental Treatment2 Interventions
Participants with second-line (2L) non-small cell lung cancer (NSCLC) will receive TAK-500, infusion, intravenously, in a 42-day treatment cycle (Q2W or Q3W) with pembrolizumab 200 mg infusion, intravenously, in a 42-day treatment cycle (Q3W) for up to 1 year. The recommended dose (RDE 1) and schedule of TAK-500 for expansion will be based on the results of the TAK-500 in combination with pembrolizumab Dose Escalation arm.
Group VIII: Dose Escalation: TAK-500 Single Agent (SA)Experimental Treatment1 Intervention
TAK-500 dose escalation starting at 8 microgram per kilogram (mcg/kg), infusion, intravenously, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) or once on Day 1, 15 and 29 of each 42-day treatment cycle (once every 2 weeks, Q2W), for up to 1 year.
Group IX: Dose Escalation: TAK-500 + PembrolizumabExperimental Treatment2 Interventions
TAK-500, infusion, intravenously, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) or once on Day 1, 15 and 29 of each 42-day treatment cycle (once every 2 weeks, Q2W), for up to 1 year, along with pembrolizumab 200 milligram (mg) infusion, intravenously, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year. The exact starting dose of TAK-500 will be determined from the results of the TAK-500 SA arm dose escalation.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Sarah Cannon Research InstituteDenver, CO
Univeristy of Alabama at BirminghamBirmingham, AL
City of Hope Comprehensive Cancer CenterDuarte, CA
Sylvester Comprehensive Cancer CenterMiami, FL
More Trial Locations
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Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials
1255
Patients Recruited
4,219,000+

Findings from Research

Pembrolizumab: A Review in Advanced Melanoma.Deeks, ED.[2022]
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.
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]
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond.Pai-Scherf, L., Blumenthal, GM., Li, H., et al.[2022]
Long-Term Overall Survival From KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin With or Without Pembrolizumab as First-Line Therapy for Advanced Nonsquamous NSCLC.Awad, MM., Gadgeel, SM., Borghaei, H., et al.[2021]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]
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.
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma.Chuk, MK., Chang, JT., Theoret, MR., et al.[2021]
Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001.Hamid, O., Robert, C., Daud, A., et al.[2023]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis.Jeon, WJ., Nguyen, J., Castillo, DR., et al.[2023]
New Approved Use for Keytruda.Aschenbrenner, DS.[2022]
Pembrolizumab Approved for Esophageal or Gastroesophageal Cancer.Aschenbrenner, DS.[2023]

References

Pembrolizumab: A Review in Advanced Melanoma. [2022]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond. [2022]
Long-Term Overall Survival From KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin With or Without Pembrolizumab as First-Line Therapy for Advanced Nonsquamous NSCLC. [2021]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
Five-year survival outcomes for patients with advanced melanoma treated with pembrolizumab in KEYNOTE-001. [2023]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
New Approved Use for Keytruda. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Pembrolizumab Approved for Esophageal or Gastroesophageal Cancer. [2023]