70 Participants Needed

Cediranib + Olaparib vs Bevacizumab for Recurrent Glioblastoma

Recruiting at 28 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: National Cancer Institute (NCI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does mention that you cannot use certain medications that strongly interact with the trial drugs. You should discuss your current medications with the study team to ensure they are not prohibited.

What data supports the effectiveness of the drug Bevacizumab for recurrent glioblastoma?

Research shows that Bevacizumab, when used alone or with other drugs like irinotecan, can be effective for patients with recurrent glioblastoma, a type of brain cancer. It has been studied in several trials and shown to help manage symptoms and slow disease progression.12345

Is the combination of Cediranib, Olaparib, and Bevacizumab safe for treating recurrent glioblastoma?

Bevacizumab has been shown to have manageable side effects, with severe treatment-related issues occurring in only a small number of patients. Cediranib has been studied in combination with other treatments for glioblastoma, but specific safety data for the combination of Cediranib, Olaparib, and Bevacizumab is not detailed in the available research.36789

How is the drug combination of Cediranib, Olaparib, and Bevacizumab unique for treating recurrent glioblastoma?

This drug combination is unique because it combines Cediranib, which blocks blood vessel growth in tumors, with Olaparib, a drug that targets cancer cell repair mechanisms, and Bevacizumab, which also inhibits blood vessel growth. This multi-targeted approach aims to enhance treatment effectiveness by attacking the tumor from different angles.910111213

What is the purpose of this trial?

This trial compares two treatments for patients with glioblastoma that has returned. One treatment uses pills that block enzymes needed for tumor growth. The other treatment uses an IV drug that helps the immune system fight cancer and prevents tumors from growing. The goal is to see which treatment works better at stopping the cancer from progressing.

Research Team

IA

Isabel Arrillaga-Romany

Principal Investigator

Dana-Farber - Harvard Cancer Center LAO

Eligibility Criteria

This trial is for adults with recurrent glioblastoma who've had prior radiotherapy and temozolomide treatment. Eligible participants must have stable or decreasing corticosteroid doses, adequate organ function, no severe allergies to the drugs being tested, and not be pregnant or breastfeeding. They should agree to use contraception and have a life expectancy of at least 3 months.

Inclusion Criteria

Leukocytes >= 3,000/mcL
My GBM has recurred no more than twice.
It's been over 12 weeks since my last radiotherapy, or my cancer has grown outside the treated area if it's been less.
See 18 more

Exclusion Criteria

I have not had an abdominal abscess in the last 6 months.
I have never had pneumonitis.
Participants may not have a dependency on IV hydration or total parenteral nutrition (TPN)
See 26 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either olaparib and cediranib maleate or bevacizumab. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

6 months
Bi-weekly visits for Arm B, monthly visits for Arm A

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days and then periodically for 3 years.

3 years

Treatment Details

Interventions

  • Bevacizumab
  • Cediranib Maleate
  • Olaparib
Trial Overview The study compares cediranib maleate plus olaparib against bevacizumab in treating recurrent glioblastoma. Cediranib maleate and olaparib are thought to block enzymes needed for tumor growth, while bevacizumab is an immunotherapy that may inhibit cancer spread.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm B (bevacizumab)Experimental Treatment1 Intervention
Patients receive bevacizumab IV over 30-90 minutes every 2 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (olaparib, cediranib maleate)Experimental Treatment3 Interventions
Patients receive olaparib PO BID and cediranib maleate PO once QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:

🇪🇺
Approved in European Union as Avastin for:
  • Colorectal cancer
  • Breast cancer
  • Non-small cell lung cancer
  • Renal cell carcinoma
  • Ovarian cancer
🇺🇸
Approved in United States as Avastin for:
  • Colorectal cancer
  • Non-small cell lung cancer
  • Glioblastoma
  • Renal cell carcinoma
  • Cervical cancer
  • Ovarian cancer
🇯🇵
Approved in Japan as Avastin for:
  • Colorectal cancer
  • Non-small cell lung cancer
  • Breast cancer
  • Renal cell carcinoma
  • Ovarian cancer
🇨🇦
Approved in Canada as Avastin for:
  • Colorectal cancer
  • Non-small cell lung cancer
  • Breast cancer
  • Renal cell carcinoma
  • Ovarian cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a study of 48 patients with recurrent glioblastoma, single-agent bevacizumab demonstrated significant biological activity, with 71% of patients achieving a radiographic response and a median progression-free survival of 16 weeks.
However, the combination of bevacizumab with irinotecan showed no objective responses, highlighting that while bevacizumab is effective as a standalone treatment, its efficacy may not extend when combined with certain other therapies.
Phase II trial of single-agent bevacizumab followed by bevacizumab plus irinotecan at tumor progression in recurrent glioblastoma.Kreisl, TN., Kim, L., Moore, K., et al.[2022]
Bevacizumab, a monoclonal antibody targeting VEGF, has shown improved patient outcomes in recurrent glioblastoma (GBM) when used in combination with chemotherapy, leading to its accelerated approval by the FDA based on positive results from phase 2 studies.
The treatment is associated with manageable toxicity, as severe adverse events occur in only a small percentage of patients, making it a safer option for those with recurrent GBM.
Bevacizumab for the treatment of recurrent glioblastoma.Chamberlain, MC.[2023]
In a phase II clinical trial involving 158 patients with newly diagnosed glioblastoma, cediranib combined with radiation and temozolomide significantly improved 6-month progression-free survival (PFS) to 46.6% compared to 24.5% for the placebo group (P = 0.005).
Although cediranib showed efficacy in prolonging PFS, it was associated with a higher incidence of grade ≥3 adverse events compared to placebo (P = 0.02), and there was no significant difference in overall survival between the two treatment groups.
NRG/RTOG 0837: Randomized, phase II, double-blind, placebo-controlled trial of chemoradiation with or without cediranib in newly diagnosed glioblastoma.Batchelor, TT., Won, M., Chakravarti, A., et al.[2023]

References

Role of delayed salvage bevacizumab at symptomatic progression of chemorefractory glioblastoma. [2020]
Phase II trial of single-agent bevacizumab followed by bevacizumab plus irinotecan at tumor progression in recurrent glioblastoma. [2022]
Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. [2023]
Bevacizumab Alone and in Combination With Irinotecan in Recurrent Glioblastoma. [2023]
Phase 2 study of carboplatin, irinotecan, and bevacizumab for recurrent glioblastoma after progression on bevacizumab therapy. [2022]
Bevacizumab for the treatment of recurrent glioblastoma. [2023]
NRG/RTOG 0837: Randomized, phase II, double-blind, placebo-controlled trial of chemoradiation with or without cediranib in newly diagnosed glioblastoma. [2023]
A Randomized Phase II Trial (TAMIGA) Evaluating the Efficacy and Safety of Continuous Bevacizumab Through Multiple Lines of Treatment for Recurrent Glioblastoma. [2020]
What have we learned from trials on antiangiogenic agents in glioblastoma? [2014]
10.United Statespubmed.ncbi.nlm.nih.gov
Multi-Center Randomized Phase II Study Comparing Cediranib plus Gefitinib with Cediranib plus Placebo in Subjects with Recurrent/Progressive Glioblastoma. [2021]
Cediranib, a pan-inhibitor of vascular endothelial growth factor receptors, inhibits proliferation and enhances therapeutic sensitivity in glioblastoma cells. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Phase III randomized trial comparing the efficacy of cediranib as monotherapy, and in combination with lomustine, versus lomustine alone in patients with recurrent glioblastoma. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Phase II study of cediranib, an oral pan-vascular endothelial growth factor receptor tyrosine kinase inhibitor, in patients with recurrent glioblastoma. [2022]
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